Professional Documents
Culture Documents
Table of Contents
Chairmans Letter ............................................................................................................................ 5
Summary of Recommendations.....................................................................................................14
The Drug Addiction and Opioid Crisis.......................................................................................... 21
Origins of the Current Crisis ......................................................................................................21
Magnitude and Demographics ...................................................................................................25
Newly Emerging Threats ...........................................................................................................28
Pathways to Opioid Use Disorder (Including Heroin) from Prescription Opioids ....................29
Health, Financial, and Social Consequences .............................................................................31
Drug Overdose Deaths ...............................................................................................................34
Substance Use Treatment Availability....................................................................................... 34
Systems Approach to Solutions .................................................................................................38
Federal Funding and Programs ......................................................................................................39
Streamlining Federal Funding for Opioids and Consideration of State Administrators ............39
Funding Effective Opioid-Related Programs .............................................................................40
Opioid Addiction Prevention .........................................................................................................41
Evidence-based Prevention Programs ........................................................................................ 43
SBIRT as a School Prevention Strategy .................................................................................44
Mass Media Public Education Campaigns ................................................................................46
Media Campaign Focusing on Opioids ..................................................................................47
Opioid Prescription Practices .....................................................................................................49
Improving upon the CDC Guideline for Prescribing Opioids for Chronic Pain and
Provider/Prescriber Education................................................................................................ 49
Enhancing Prescription Drug Monitoring Programs (PDMP) ...............................................54
Prescription Take-Back Programs and Drug Disposal ........................................................... 57
Pain Level as an HHS Evaluation Criteria .................................................................................58
Reimbursement for Non-Opioid Pain Treatments .....................................................................59
Reducing and Addressing the Availability of Illicit Opioids .....................................................60
Improving Data Collection and Analytics ..............................................................................60
Disrupting the Illicit Fentanyl Supply ....................................................................................63
Interdiction and Detection Challenges ...................................................................................65
Protecting First Responders from Harmful Effects Resulting from Exposure to Fentanyl and
other Synthetic Opioids ..........................................................................................................67
DRAFT/ADVISORY/CONSULTATIVE/DELIBERATIVE/CONFIDENTIAL
Opioid Addiction Treatment, Overdose Reversal, and Recovery .................................................69
Drug Addiction Treatment Services .......................................................................................... 69
Increase Screenings and Referrals to Treatment through CMS Quality Measures ................69
Evidence-based Improvements to Treatment .........................................................................70
Insurance and Reimbursement Barriers to Accessing MAT ..................................................71
Enforcing the Mental Health Parity and Addiction Equity Act (MHPAEA) ......................... 73
MAT in the Criminal Justice System .....................................................................................74
Drug Courts and Diversion Programs ....................................................................................75
Addiction Services Workforce and Training Needs............................................................... 76
Response to Overdose ................................................................................................................79
Expanded Access and Administration of Naloxone ............................................................... 79
Overdose to Treatment and Recovery ....................................................................................81
Recovery Support Services ........................................................................................................82
Impact on Families and Children ........................................................................................... 82
Supporting Collegiate Recovery and Changing the Culture on College Campuses ..............83
Employment Opportunities for Americans in Recovery ........................................................ 85
Support Recovery Housing ....................................................................................................86
Research & Development ..............................................................................................................88
New Pain, Overdose, and MAT Medications ............................................................................88
Medical Technology Devices.....................................................................................................90
FDA Post-Market Research and Surveillance Programs ........................................................... 91
Conclusion .....................................................................................................................................92
Current Federal Programs and Funding Landscape ......................................................................95
Overview ....................................................................................................................................95
FY 2018 Funding Specific to Americas Opioid Crisis ............................................................. 95
The Comprehensive Addiction and Recovery Act (CARA) ..................................................98
21st Century Cures Act ...........................................................................................................98
FY 2018 Consolidated Federal Drug Control Budget ............................................................... 99
Prevention............................................................................................................................... 99
Treatment and Recovery ......................................................................................................101
Domestic Law Enforcement .................................................................................................103
Interdiction ........................................................................................................................... 104
International Efforts .............................................................................................................105
DRAFT/ADVISORY/CONSULTATIVE/DELIBERATIVE/CONFIDENTIAL
Charter, Presidents Commission on Combating Drug Addiction and the Opioid Crisis ...........109
Appendices ..................................................................................................................................112
Appendix 1. Acronyms ...........................................................................................................115
Appendix 2. History of Opiate Use and Abuse .......................................................................117
Appendix 3. Interim Report, Presidents Commission on Combating Drug Addiction and the
Opioid Crisis ............................................................................................................................ 111
Appendix 4. Fentanyl Safety Recommendations for First Responders ..................................127
References ............................................................................................................................................ 128
Summary of Recommendations
Federal Funding and Programs
1. The Commission urges Congress and the Administration to block grant federal funding for
opioid-related and SUD-related activities to the states, where the battle is happening every
day. There are multiple federal agencies and multiple grants within those agencies that cause
states a significant administrative burden from an application and reporting perspective.
Creating uniform block grants would allow more resources to be spent on administering life-
saving programs. This was a request to the Commission by nearly every Governor, regardless
of party, across the country.
2. The Commission believes that ONDCP must establish a coordinated system for tracking all
federally-funded initiatives, through support from HHS and DOJ. If we are to invest in
combating this epidemic, we must invest in only those programs that achieve quantifiable
goals and metrics. We are operating blindly today; ONDCP must establish a system of
tracking and accountability.
3. To achieve accountability in federal programs, the Commission recommends that ONDCP
review is a component of every federal program and that necessary funding is provided for
implementation. Cooperation by federal agencies and the states must be mandated.
PDMP Enhancements
12. The Commission recommends the Administration's support of the Prescription Drug
Monitoring (PDMP) Act to mandate states that receive grant funds to comply with PDMP
requirements, including data sharing. This Act directs DOJ to fund the establishment and
maintenance of a data-sharing hub.
13. The Commission recommends federal agencies mandate PDMP checks, and consider
amending requirements under the Emergency Medical Treatment and Labor Act (EMTALA),
which requires hospitals to screen and stabilize patients in an emergency department,
regardless of insurance status or ability to pay.
14. The Commission recommends that PDMP data integration with electronic health records,
overdose episodes, and SUD-related decision support tools for providers is necessary to
increase effectiveness.
15. The Commission recommends ONDCP and DEA increase electronic prescribing to prevent
diversion and forgery. The DEA should revise regulations regarding electronic prescribing
for controlled substances.
16. The Commission recommends that the Federal Government work with states to remove legal
barriers and ensure PDMPs incorporate available overdose/naloxone deployment data,
including the Department of Transportations (DOT) Emergency Medical Technician (EMT)
overdose database. It is necessary to have overdose data/naloxone deployment data in the
PDMP to allow users of the PDMP to assist patients.
Supply Reduction and Enforcement Strategies
17. The Commission recommends community-based stakeholders utilize Take Back Day to
inform the public about drug screening and treatment services. The Commission encourages
more hospitals/clinics and retail pharmacies to become year-round authorized collectors and
explore the use of drug deactivation bags.
18. The Commission recommends that CMS remove pain survey questions entirely on patient
satisfaction surveys, so that providers are never incentivized for offering opioids to raise their
survey score. ONDCP and HHS should establish a policy to prevent hospital administrators
from using patient ratings from CMS surveys improperly.
19. The Commission recommends CMS review and modify rate-setting policies that discourage
the use of non-opioid treatments for pain, such as certain bundled payments that make
alternative treatment options cost prohibitive for hospitals and doctors, particularly those
options for treating immediate post-surgical pain.
20. The Commission recommends a federal effort to strengthen data collection activities
enabling real-time surveillance of the opioid crisis at the national, state, local, and tribal
levels.
21. The Commission recommends the Federal Government work with the states to develop and
implement standardized rigorous drug testing procedures, forensic methods, and use of
appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not
have sufficiently accurate and systematic data from medical examiners around the country to
determine overdose deaths, both in their cause and the actual number of deaths.
22. The Commission recommends reinstituting the Arrestee Drug Abuse Monitoring (ADAM)
program and the Drug Abuse Warning Network (DAWN) to improve data collection and
provide resources for other promising surveillance systems.
23. The Commission recommends the enhancement of federal sentencing penalties for the
trafficking of fentanyl and fentanyl analogues.
24. The Commission recommends that federal law enforcement agencies expressly target Drug
Trafficking Organizations and other individuals who produce and sell counterfeit pills,
including through the internet.
25. The Commission recommends that the Administration work with Congress to amend the law
to give the DEA the authority to regulate the use of pill presses/tableting machines with
requirements for the maintenance of records, inspections for verifying location and stated
use, and security provisions.
26. The Commission recommends U.S. Customs and Border Protection (CBP) and the U.S.
Postal Inspection Service (USPIS) use additional technologies and drug detection canines to
expand efforts to intercept fentanyl (and other synthetic opioids) in envelopes and packages
at international mail processing distribution centers.
27. The Commission recommends Congress and the Federal Government use advanced
electronic data on international shipments from high-risk areas to identify international
suppliers and their U.S.-based distributors.
28. The Commission recommends support of the Synthetics Trafficking and Overdose
Prevention (STOP) Act and recommends the Federal Government work with the
international community to implement the STOP Act in accordance with international laws
and treaties.
29. The Commission recommends a coordinated federal/DEA effort to prevent, monitor and
detect the diversion of prescription opioids, including licit fentanyl, for illicit distribution or
use.
30. The Commission recommends the White House develop a national outreach plan for the
Fentanyl Safety Recommendations for First Responders. Federal departments and agencies
should partner with Governors and state fusion centers to develop and standardize data
collection, analytics, and information-sharing related to first responder opioid-intoxication
incidents.
41. The Commission recommends that federal agencies revise regulations and reimbursement
policies to allow for SUD treatment via telemedicine.
42. The Commission recommends further use of the National Health Service Corp to supply
needed health care workers to states and localities with higher than average opioid use and
abuse.
43. The Commission recommends the National Highway Traffic Safety Administration
(NHTSA) review its National Emergency Medical Services (EMS) Scope of Practice Model
with respect to naloxone, and disseminate best practices for states that may need statutory or
regulatory changes to allow Emergency Medical Technicians (EMT) to administer naloxone,
including higher doses to account for the rising number of fentanyl overdoses.
44. The Commission recommends HHS implement naloxone co-prescribing pilot programs to
confirm initial research and identify best practices. ONDCP should, in coordination with
HHS, disseminate a summary of existing research on co-prescribing to stakeholders.
45. The Commission recommends HHS develop new guidance for Emergency Medical
Treatment and Labor Act (EMTALA) compliance with regard to treating and stabilizing
SUD patients and provide resources to incentivize hospitals to hire appropriate staff for their
emergency rooms.
46. The Commission recommends that HHS implement guidelines and reimbursement policies
for Recovery Support Services, including peer-to-peer programs, jobs and life skills training,
supportive housing, and recovery housing.
47. The Commission recommends that HHS, the Substance Abuse and Mental Health Services
Administration (SAMHSA), and the Administration on Children, Youth and Families
(ACYF) should disseminate best practices for states regarding interventions and strategies to
keep families together, when it can be done safely (e.g., using a relative for kinship care).
These practices should include utilizing comprehensive family centered approaches and
should ensure families have access to drug screening, substance use treatment, and parental
support. Further, federal agencies should research promising models for pregnant and post-
partum women with SUDs and their newborns, including screenings, treatment interventions,
supportive housing, non-pharmacologic interventions for children born with neonatal
abstinence syndrome, medication-assisted treatment (MAT) and other recovery supports.
48. The Commission recommends ONDCP, the Substance Abuse and Mental Health Services
Administration (SAMHSA), and the Department of Education (DOE) identify successful
college recovery programs, including "sober housing" on college campuses, and provide
support and technical assistance to increase the number and capacity of high-quality
programs to help students in recovery.
49. The Commission recommends that ONDCP, federal partners, including DOL, large
employers, employee assistance programs, and recovery support organizations develop best
practices on SUDs and the workplace. Employers need information for addressing employee
alcohol and drug use, ensure that employees are able to seek help for SUDs through
employee assistance programs or other means, supporting health and wellness, including
SUD recovery, for employees, and hiring those in recovery.
50. The Commission recommends that ONDCP work with the DOJ, DOL, the National Alliance
for Model State Drug Laws, the National Conference of State Legislatures, and other
stakeholders to develop model state legislation/regulation for states to decouple felony
convictions and eligibility for business/occupational licenses, where appropriate.
51. The Commission recommends that ONDCP, federal agencies, the National Alliance for
Recovery Residents (NARR), the National Association of State Alcohol and Drug Abuse
Directors (NASADAD), and housing stakeholders should work collaboratively to develop
quality standards and best practices for recovery residences, including model state and local
policies. These partners should identify barriers (such as zoning restrictions and
discrimination against MAT patients) and develop strategies to address these issues.
Research and Development
52. The Commission recommends federal agencies, including HHS (National Institutes of
Health, CDC, CMS, FDA, and the Substance Abuse and Mental Health Services
Administration), DOJ, the Department of Defense (DOD), the VA, and ONDCP, should
engage in a comprehensive review of existing research programs and establish goals for pain
management and addiction research (both prevention and treatment).
53. The Commission recommends Congress and the Federal Government provide additional
resources to the National Institute on Drug Abuse (NIDA), the National Institute of Mental
Health (NIMH), and National Institute on Alcohol Abuse and Alcoholism (NIAAA) to fund
the research areas cited above. NIDA should continue research in concert with the
pharmaceutical industry to develop and test innovative medications for SUDs and OUDs,
including long-acting injectables, more potent opioid antagonists to reverse overdose, drugs
used for detoxification, and opioid vaccines.
54. The Commission recommends further research of Technology-Assisted Monitoring and
Treatment for high-risk patients and SUD patients. CMS, FDA, and the United States
Preventative Services Task Force (USPSTF) should implement a fast-track review process
for any new evidence-based technology supporting SUD prevention and treatments.
55. The Commission recommends that commercial insurers and CMS fast-track creation of
Healthcare Common Procedure Coding System (HCPCS) codes for FDA-approved
technology-based treatments, digital interventions, and biomarker-based interventions. NIH
should develop a means to evaluate behavior modification apps for effectiveness.
56. The Commission recommends that the FDA establish guidelines for post-market surveillance
related to diversion, addiction, and other adverse consequences of controlled substances.
The Drug Addiction and Opioid Crisis
The primary goal of the Presidents Commission on Combating Drug Addiction and the Opioid
Crisis is to develop an effective set of recommendations for the President to combat the opioid
crisis and drug addiction in our nation. Many of the recommendations that follow will require
appropriations from Congress into the Public Health Emergency Fund, for block grants to states
and to DOJ for enforcement and judicial improvements. Notwithstanding this core mission, it is
vital to address the influences that transformed the United States into the world leader of opioid
prescribing, opioid addiction, and opioid overdose deaths. It is not the Commission's charge to
quantify the amount of these resources, so we do not do so in this report.
The Commission urges Congress to respond to the President's declaration of a public health
emergency and fulfill their constitutionally delegated duty and appropriate sufficient funds to
implement the Commission's recommendations. 175 Americans are dying every day. Congress
must act.
Pain patient advocacy: Advocacy for pain management and/or the use of opioids4,5,6 by
pain patients was promoted, not only by patients, but also by some physicians. One notable
physician stated: make pain visible ensure patients a place in the communications
loop assess patient satisfaction; and work with narcotics control authorities to encourage
therapeutic opiate use therapeutic use of opiate analgesics rarely results in addiction.7
The opioid pharmaceutical manufacturing and supply chain industry: One
pharmaceutical company sponsored over 20,000 educational events for physicians and others
on managing pain with opioids, claiming their potential for addiction was low.8 Yet, warning
signs of the addictive potential of oxycodone and similar opioids long predated this period: in
1963, Bloomquist wrote that dihydrohydroxycodeinone (oxycodone, Percodan), although
a useful analgesic retains addiction potential comparable to that of morphine. This fact
should be considered when it is prescribed. Because of increasing numbers of addicts to this
drug in the State of California, the California Medical Association Committee on Dangerous
Drugs and the House of Delegates has recommended that oxycodone-containing drugs be
returned to the triplicate prescription list as they were originally in 1949. This
recommendation failed to pass the legislature.9 Similar warnings followed.
Aggressive promotion of an oxycodone brand from 1997-2002 led to a 10-fold rise in
prescriptions to treat moderate to severe noncancer pain, and increases in prescribing of other
opioids. Subsequently, the highest strengths permissible was increased for opioid-tolerant
patients, likely contributing to its misuse. Extended-release (ER) formulations and delayed
absorption were marketed as reducing abuse liability, but crushing the pills allowed users to
snort or inject the drugs.10,11 There are now at least five marketed opioids that carry abuse-
deterrent labeling. It has been hypothesized that the marked rise in heroin and other illicit
synthetic opioids is, in part, associated with unintended consequences of reformulation of
OxyContin, and a reduced supply and greater expense of prescription opioids.12,13
To this day, the opioid pharmaceutical industry influences the nations response to the
crisis.14 For example, during the comment phase of the guideline developed by the Centers
for Disease Control and Prevention (CDC) for pain management, opposition to the guideline
was more common among organizations with funding from opioid manufacturers than those
without funding from the life sciences industry.15
Rogue pharmacies and unethical physician prescribing: The key contributors of the large
number of diverted opioids were unrestrained distributors, rogue pharmacies, unethical
physicians, and patients whose opioid medications were diverted, or other patients who sold
and profited from legitimately prescribed opioids.16
Pain as the fifth vital sign: The phrase, pain as the fifth vital sign, was initially
promoted by the American Pain Society in 1995, to elevate awareness of pain treatment
among healthcare professionals; Vital Signs are taken seriously. If pain were assessed with
the same zeal as other vital signs are, it would have a much better chance of being treated
properly. We need to train doctors and nurses to treat pain as a vital sign. Quality care means
that pain is measured and treated.17
The Veterans Administration (VA)18 and then the Joint Commission on Accreditation of
Healthcare Organizations (the Joint Commission) designated pain as a fifth vital sign.19,20
The Joint Commission accredits and certifies health care organizations. Certification has
implications for objective assessment of clinical excellence, and for contracting and
reimbursement. The Joint Commissions standards for pain assessment in 2000 were a bold
attempt to address widespread underassessment and undertreatment of pain,21 even though
the health care community was not advocating for a regulatory approach to pain
management.22 The standards raised concerns that requiring all patients to be screened for the
presence of pain and raising pain treatment to patients rights issue could lead to overreliance
on opioids.
The Joint Commission received sponsorship for developing educational materials from an
opioid pharmaceutical company, one of over 20,000 pain-related educational programs
through direct sponsorship or financial grants. It was unaware that the science behind their
claims and the advice of experts in the field were erroneous.23 This designation set in
motion a growing compulsion to detect and treat pain, especially to prescribe opioids beyond
traditional boundaries of treating acute, postoperative, procedural pain and end-of-life care.
The surge in opioid supply escalated into opioid-related misuse, diversion, use disorder, and
overdose deaths. Administrators, regulatory bodies, and insurers collectively pressured
physicians to address patient satisfaction with aggressive pain management.24 However, the
concept that iatrogenic addiction was rare and that long-acting opioids were less addictive
had been widely repeated, and studies refuting these claims were not published until years
later. The Joint Commission has since eliminated the requirement that pain be assessed in all
patients, except for patients receiving behavioral health care and established much stricter
processes to review any corporate sponsorship of educational programs. In 2016, the Joint
Commission began to revise its pain standards,25 which will go into effect in January 2018.
Inadequate oversight by the Food and Drug Administration (FDA): The FDA is the sole
federal authority responsible for protecting public health by assuring the safety, efficacy, and
security of human drugs, biological products, and medical devices. It approves medications
to diagnose, treat, and mitigate illnesses, after assessing their safety and efficacy. It
safeguards the nations medications by setting standards for proper prescribing of approved
drugs and post-approval surveillance. The FDA provided inadequate regulatory oversight.
Even when overdose deaths mounted and when evidence for safe use in chronic care was
substantially lacking, prior to 2001, the FDA accepted claims that newly formulated opioids
were not addictive, did not impose clinical trials of sufficient duration to detect addiction, or
rigorous post-approval surveillance of adverse events, such as addiction.
The FDA also failed to assess the risks associated with deliberate diversion and misuse of
opioids, risks that conceivably outweighed the intended benefits for patients if used as
directed. They accepted the pharmaceutical industrys claim that iatrogenic addiction was
very rare and that the delayed absorption of OxyContin reduced the abuse liability of the
drug.26 By 2001, the FDA removed these unsubstantiated claims from OxyContins labeling.
In March 2016, the FDA requested from the National Academies of Sciences, Engineering,
and Medicine (NASEM) and received on July 13, 2017, a summary of the current status of
science regarding prescription opioid abuse and misuse, and the role of opioids in pain
management.27 The current FDA Commissioner has stated a strong commitment to using the
regulatory authority of the FDA to mitigate the adverse consequences of opioid use.28
Reimbursement for prescription opioids by health care insurers: Sales of prescription
opioids in the U.S. nearly quadrupled from 1999 to 2014,29 largely paid for by insurance
carriers. It is estimated that 1 out of 5 patients with non-cancer pain or pain-related diagnoses
are prescribed opioids in office-based settings.30 From 2007 to 2012, the rate of opioid
prescribing steadily increased amongst specialists more likely to manage acute and chronic
pain (pain medicine [49%], surgery [37%], physical medicine/rehabilitation [36%]).
Insurance carriers, including Medicare Part D plans, did not serve as a stop-gap to the huge
influx of opioid prescriptions.
Medical education: Medical education has been deficient in pain management, opioid
prescribing, screening for, and treating addictions.31 During the 1990s, the pain movement
should have alerted medical education institutions and creators of continuing medical
education courses to address this issue. In some medical schools and some specialties, it
remains inadequate to this day.32 One strategy promoted 10 years ago to stratify patients risk
for opioid misuse and overdose was the screening of patients for substance use disorders
(SUDs), especially pain patients.33 Implementation of Screening, Brief Interventions, and
Referral to Treatment (SBIRT) in healthcare systems was incentivized with billing codes. 34
SBIRT was mainstreamed into health care reform, but has yet to be incorporated nationally
into medical curricula, or applied as routine care. Nor do core curricula necessarily address
addictions, treatment options, or stress the need to screen for substance use and mental
health.
Lack of patient education: Patients and their families are not often fully informed regarding
whether their prescriptions are opioids, the risks of opioid addiction or overdose, control and
diversion, dose escalation, or use with alcohol or benzodiazepines.
Public demand evolves into reimbursement and physician quality ratings pegged to
patient satisfaction scores: Today, the use of opioids for chronic non-cancer pain remains
controversial for the same reasons their use declined and was avoided at the turn of the 20th
century: the potential for misuse and addiction, insufficient high-quality evidence of efficacy
with long-term use, poor functional outcomes, overdose and death.
Yet, a strong public demand for opioids continues to pressure clinicians to prescribe opioids
persists. As an example, a recent survey of Emergency Department (ED) physicians indicated
that 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative
and regulatory criticism. Uniformly, they voiced concern about excessive emphasis on
patient satisfaction scores by reimbursement entities as a means of evaluating their patient
management. The physician requirement to address pain as the "fifth vital sign" persists,35
and reimbursement metrics based on patient satisfaction may have inadvertently created an
environment conducive to exploitation by prescription opioid abusers.36 There are legitimate
circumstances for which opioids are an appropriate therapy. But many current institutional
and societal issues continue to pressure physicians to prescribe opioids when they are not
clinically appropriate.
Prior to this year, poor patient satisfaction with pain care could lead to reduced hospital
reimbursement by Medicare through Value-Based Purchasing (VBP). There are often higher
costs or no specific reimbursements for alternative pain management strategies, alternative
pain intervention strategies, or spending time to educate patients about the risks of opioids.
Further, failing to provide adequate pain relief can be grounds for malpractice claims or
medical board action.
Lack of foresight of unintended consequences: As prescription drugs came under tighter
scrutiny and access became more limited (via abuse-deterrent formulations and more
cautious prescribing), market forces responded by providing less expensive and more
accessible illicit opioids. Increases in overdose death numbers due to prescription opioids
have transitioned to overdoses largely due to heroin and, increasingly, fentanyl. 37 Locally,
this trend may have been driven, in part, by tightening controls on prescription opioids.
Physicians curtailed opioid prescriptions without guidelines on tapering and without
determination of whether patients had developed an opioid use disorder (OUD), and if so,
how to respond.38
The availability of cheaper heroin also drove prescription opioid misusers to illicit opioids.
Black market heroin is currently much less expensive than diverted prescription opioids, and
fentanyl is even much less expensive per dose than heroin. Predictable from the economics of
the two drug categories, the prescription drug overdose problem has decreased, but not the
overall number of opioid-related deaths.
Treatment services insufficient to meet demand and to provide medication-assisted
treatment (MAT): As OUDs increased dramatically over the past 15 years, quality
treatment services and the associated workforce did not expand in response to the growing
crisis.
Lack of national prevention strategies: Prevention strategies focusing on specific illicit
drugs for vulnerable populations - adolescents, college age youth, pregnant women,
unemployed men, and other - and for influencers, (parents, families) dont exist or have not
been tested adequately.
Table 1. Treatment Facilities for Substance Use Disorder by Level of Urbanization, 2016
Number of Counties Percent of Counties in Level of Urbanization
No
No SUD No SUD
Treatment No SUD No SUD
Treatment Treatment
Level of Urbanization Facilities Treatment No Treatment
Facilities Facilities
for Facilities Treatment Facilities
Total with Total with
Substance that Facilities that
Opioid Opioid
Use accept for SUD accept
Treatment Treatment
Disorder Medicaid Medicaid
Programs Programs
(SUD)
Large Central Metro 68 7 8 7 100% 10% 12% 10%
Large Fringe Metro 368 88 259 104 100% 24% 70% 28%
Medium Metro 373 100 242 116 100% 27% 65% 31%
Small Metro 358 100 267 121 100% 28% 75% 34%
Micropolitan (non-metro) 641 157 586 204 100% 24% 91% 32%
Non-core (non-metro) 1,333 728 1,321 800 100% 55% 99% 60%
United States 3,141 1,180 2,683 1,352 100% 38% 85% 43%
Figure 1. Counties with No Treatment Facilities for Substance Use Disorder by Level of Urbanization
Furthermore, 85% of all U.S. counties have no OTPs that provide MAT for people diagnosed
with an OUD (Table 1). These facilities are concentrated in large central metropolitan areas,
where 88% of these counties have at least one treatment facility offering OTP (only 12% of these
central metropolitan counties do not have OTP facilities). For other metropolitan counties, 65 to
75% do not have OTP facilities, but among rural counties, almost all (91 to 99%) lack an OTP
facility.
Figure 2 shows counties that did not have an OTP facility as of January 2016; as with SUD
treatment facilities generally, the vast majority of these are rural counties. Many large fringe and
medium metropolitan counties appear as doughnut-shaped areas around core locations where
OTP facilities are located, but many rural counties are located far from OTP facilities.
Data were also obtained on the locations of physicians that can dispense buprenorphine from
their offices.122 Physicians can provide MAT for OUD treatment in settings other than OTP
facilities, including dispensing buprenorphine from their offices. To prescribe or dispense
buprenorphine for OUD treatment, qualified physicians must receive waivers from the DEA
under the terms of the Drug Addiction Treatment Act of 2000 (DATA 2000). As of February
2016, 47% of counties nationwide did not have a waived physician (Table 2). However, when
classifying the county locations of waived physicians according to level of urbanization, the
rural-urban disparities become clear. None of the large central metro counties, and 72% of the
most rural counties, did not have a waived physician (Figure 3). The vast majority of counties
without buprenorphine-waived doctors are rural. However, it is worth noting that the number of
patients a physician can treat with buprenorphine is capped; so, having a waived physician
within a geographic area is not necessarily indicative of sufficient access for county or city
residents.
While utilization of SUD treatment services in both rural and urban areas is challenged by many
factors, the nature of these challenges varies. For example, findings from focus groups of
counselors in rural areas noted a dearth of good facilities, poor access due to clients living far
away from treatment centers, reliance on friends or family for transportation, and a need for basic
medical and dental services. These factors were not mentioned by urban counselors.123
A recent study of SUD treatment facilities that accept Medicaid also found that rural residents
are less likely to have such a facility.124
Figure 3. Counties with No Physicians with Buprenorphine Waivers by Level of Urbanization, 2016
Systems Approach to Solutions
There has never been a time more appropriate or opportune to develop effective and cost-
effective policies for addressing substance use and disorders in our nation. A systems approach
can facilitate development of recommendations and solutions to this dynamic and ever-shifting
challenge. This report addresses solutions to each of the core components of the crisis, a
trajectory which begins with drug supply, attitudes towards drug use and knowledge of opioids,
risk factors for misusing, and progresses to addiction, transition to heroin/fentanyl, situational
factors in overdose, rescue, treatment, relapse prevention, recovery support, and continuum of
care (Figure 4). Over the past decade, large databases have accumulated to inform policies and
associated budgets.
The most urgent goals and readily
quantifiable achievements will be a reduction
in overdose episodes and deaths, increased
entry into and adherence to high quality
treatment, and a reduction in prescribed
opioids. More complex models are needed to
address whether prescribing policies result in
time-dependent reductions in prescription
opioid diversion or increase heroin/fentanyl
use, who is at risk for transitioning to heroin
or fentanyl, the incidence and prevalence of
OUD, and others. The opioid epidemic
defies medical and legal models for
addressing Figure 4. Opioid Crisis-Intervention Stages
addiction and trafficking. Limited data exists
to track the crisis and identify weaknesses in
current responses (e.g. prescribing practices, treatment availability, individuals at risk), but is
held in different databases across a multitude of public and private organizations, and significant
proportion is not in real-time.
Building a secure data foundation that promotes cross-entity collaboration while protecting
privacy is a challenging but necessary step to save lives, expand treatment options, and
effectively prevent further spread of this deadly epidemic. The data exists but resides in agency
silos, or in the private sector providing analytics for specific industries (e.g. pharmaceutical or
healthcare insurers), making it difficult to act upon the information. The Federal Government
should create an integrated data environment that brings together publicly available data
with agency-specific data to help address this epidemic. Often, the same data viewed through
a different lens can support multiple parts of the problem. For example, doctors can use
prescription drug monitoring programs (PDMPs) to check patient records, while law
enforcement can use PDMPs to identify prolific opioid prescribers and public health agencies
can use it to identify and intervene in a potential victim pool before overdoses occur different,
but all valuable uses of the same data.
This kind of effort would not require a new data warehouse or standardization initiative; the
integrated data environment can immediately integrate existing data sources.
Federal Funding and Programs
On page 87 of the report, there is a full breakdown of federal funding sources for drug-related
activities, including interdiction, prevention, and treatment. As shown in that section, the federal
funding landscape is complex, exists in silos, potentially duplicative, and supports hundreds of
on the ground programs.
1. The Commission urges Congress and the Administration to block grant federal funding
for opioid-related and SUD-related activities to the states, where the battle is happening
every day. There are multiple federal agencies and multiple grants within those
agencies that cause states a significant administrative burden from an application and
reporting perspective. Creating uniform block grants would allow more resources to be
spent on administering life-saving programs. This was a request to the Commission by
nearly every Governor, regardless of party, across the country.
2. The Commission believes that ONDCP must establish a coordinated system for
tracking all federally-funded initiatives, through support from HHS and DOJ. If we are
to invest in combating this epidemic, we must invest in only those programs that
achieve quantifiable goals and metrics. We are operating blindly today; ONDCP must
establish a system of tracking and accountability.
It is important to consider that the national crisis is not only about prescription or illicit opioids. We
are focusing on this class of substances, but prevention efforts need to be broader because the
removal of one substance conceivably will be replaced with another.
To address the opioid and addiction epidemic, it is vital to make substance use and misuse
prevention a much higher priority and stop the pipeline into addiction. In the first Commission
meeting, General Arthur Dean, speaking on behalf of Community Anti-Drug Coalitions of
America, expressed the strong belief that prevention has been underutilized, relative to its
importance and cost-effectiveness in preventing or reducing drug use and misuse and the related
human and societal costs. The American Society of Addiction Medicine (ASAM) and the
Addiction Policy Forum both recommended the launch of a national public education campaign,
similar to the one developed for the AIDS epidemic in the 1980s, to raise awareness that addiction
is not a moral failing, but rather a chronic brain disease, and that evidence-based treatment is
available.
A generalized prevention campaign should address use of illicit drugs with abuse potential, as
they can progress to addiction. Addiction is the most prevalent and costliest of neuropsychiatric
disorders and the leading cause of premature, preventable deaths and disability in the United
States. Of the ~2 million annual deaths in the United States, one-quarter are attributable to the
consequences of tobacco, alcohol, opioids, and other drugs. Drugs impact every sector of society
individuals, families, communities, healthcare systems, educational environment, workplace,
traffic safety, and the criminal justice system. Studies investigating the effects of drugs in the
brain, body, and on behavior has yielded a vast base of information over the past twenty years,
relevant and indeed critical information for public education. These research discoveries have
outsized power and potential to heighten awareness and promote prevention, but their impact has
been limited by discontinuities in translating research into effective prevention messages and
broadcasting them widely. The current opioid crisis dramatically illustrates an unfulfilled need for
expanded educational outreach to new generations of youth, their parents and the general
population. Youth are more susceptible to addiction and are a key target cohort for prevention.
The vast majority of users fall into 16-34 age category, a peak period for pregnancy, parenting,
and for adverse consequences of drugs: addiction, underemployment, health issues, accidents, and
trauma. It is well recognized that use rates are inversely correlated with perception of risk, yet
effective state-of-the-art, credible, compelling, and comprehensible information on the risks and
adverse health consequences of drugs has not been mounted to reverse these trends.
The National Institute on Drug Abuses (NIDA) Drug Facts Chat Day website
(http://drugfactsweek.drugabuse.gov/chat/) offers some insights into young peoples curiosity for
accurate information about drugs and the lack of accessibility to information. Teenagers from
around the nation are offered a day-long session to ask NIDA staff their personal question about
drugs. A sampling of questions is listed below:
What is in drugs that make it so addictive?
What should you do if a parent is doing drugs?
Do drugs kill brain cells?
Is drinking worse than smoking?
During this nations worst drug crisis, there is no more opportune time to launch a national
prevention campaign that highlights the hazards of substance use, but also focuses on the opioid
crisis: (1) to educate the public on risks and consequences of drug use in general, with emphasis
on opioids; (2) to focus on the vulnerable - adolescents, college age students, pregnant women,
those harboring a psychiatric disorder, and the elderly - and highlight the detrimental effects of
opioids; (3) to convey to parents their critical role in determining their childrens use of drugs;
(4) to show parents how to engage in crucial conversations with children about drugs; (5) to
dispel common myths and misinformation on drugs; (6) to educate families on warning signs in
family members and on reducing environmental risks for children; (7) to advance the concept of
addiction as a treatable brain disease; and (8) to tailor messages to specific populations and
communities in need. Many sources of information exist from government agencies (e.g. NIDA,
SAMHSA, National Institute on Alcohol Abuse and Alcoholism [NIAAA], DEA) or on websites
of non- and for-profit private organizations. The reach of these websites is limited, and their
impact and value undetermined. Creative strategies are needed to engage much larger populations,
with accountability on effectiveness.
Notably, recent surveys indicate that parents can be key contributors to a childs use or non-use of
drugs. Youth alcohol or marijuana use was 5-7-fold lower if parents took a strong stance against
use, compared with parents whose views were ambivalent. Systematic reviews have reinforced
this conclusion.126,127 Yet, parental knowledge is limited, as illustrated by examples
from a recent survey:
a) Nine of ten parents do not think that teens spending time on social networking sites like
Facebook are likelier to drink or use drugs. Yet, teens who spend time on a social
networking site in a typical day are much likelier to use tobacco, alcohol, and other drugs
than teens who dont spend time on a social networking site in a typical day; 128
b) When asked, do you consider it necessary to take steps to keep your child from having
access to prescriptions for painkillers such as Oxycontin, Vicodin or Percocet in your
home?, 57% of parents with prescription pain killers in their home did not consider it
necessary to prevent their child from accessing the prescriptions,129 even though more than
50% of people who misuse prescription pain killers obtained them for free from friends
and family.130 Yet, the 2016 national survey indicates that parental attitudes are critical in
determining youth drug use.131
c) One-third of parents surveyed reported that it was very likely or somewhat likely that
their teen would try drugs (including marijuana or prescription drugs without a
prescription to get high) at some point in the future. Yet, if parents are perceived to
disapprove of marijuana use, use among youth is approximately 9 times lower. 132
Parents have been under-represented in prevention programs, even though evidence is robust that
parent-based prevention programs can play a pivotal role in delaying the onset and use of alcohol
and other drugs, an influence that persists during adolescent development. Furthermore, universal
prevention programs are enhanced with inclusion of parent-based components.133 In a
systematic review of studies which combined student- and parent-based programs to prevent or
reduce adolescent alcohol, tobacco or marijuana use, effectiveness was shown in the majority of
studies.
In summary, there is a compelling need to integrate evidence-based prevention programs in large
scale outreach programs within schools. With tools for teachers and parents to enhance youth
knowledge of the dangers of drug use, early intervention strategies can be implemented for
children with environmental and individual risk factors (trauma, foster care, adverse childhood
experiences [ACEs], and developmental disorders).
Indicated interventions are directed to those who are already involved in a risky behavior,
such as substance misuse, or are beginning to have problems, but who have not yet developed
an SUD. Examples of individual intervention programs include:
o Project Toward No Drug Abuse
o BASICS
o Keepin it Real
School programs implementing environmental approaches targeting children focus on building a
repertoire of positive competencies, including in the areas of academics, self-regulation, and
social skills. Teachers can focus on interventions in the classroom for those who may need
support with self-regulation and social skills. Increasing the capacity of teachers by training
them in classroom management strategies (e.g. establishing clear rules and rewards for
compliance, teaching interactively, and promoting cooperative learning) provides them with the
skills for managing behaviors and teaching children self-regulation.144 Risk and protective
factors can be influenced by the choice of programs and policies at multiple levels, including
federal, state, community, family, school, and the individual.
One advantage of a properly implemented universal prevention intervention is that it is likely to
reach most or all the population (e.g. school-based interventions are likely to reach all students).
Targeted (selective and indicated) approaches provide more intensive services to those who are
reached. It is prudent for communities to provide a mix of universal, selective, and indicated
preventive interventions.145
5. The Commission recommends the Administration fund and collaborate with private
sector and non-profit partners to design and implement a wide-reaching, national
multi-platform media campaign addressing the hazards of substance use, the danger of
opioids, and stigma. A similar mass media/educational campaign was launched during
the AIDs public health crisis.
Improving upon the CDC Guideline for Prescribing Opioids for Chronic Pain and
Provider/Prescriber Education
In March of 2016, the CDC developed and published a guideline for prescribing opioid pain
medications for adults 18 years of age and older in primary care settings.163 This guideline is
intended to improve the communication between provider and patient about the risks and
benefits of opioid therapy for chronic pain, improve treatment safety and effectiveness of pain
treatment, and reduce the risks associated with long-term opioid therapy, including OUD and
overdose. The guideline focuses on three key areas: 1) determining when to initiate or continue
opioids for chronic pain; 2) opioid selection, dosage, duration, follow-up and discontinuation;
and 3) assessing risk and addressing harms of opioid use. Prescriptions by primary care
clinicians account for nearly half of all dispensed opioid prescriptions, and the growth in
prescribing rates among these clinicians have been above average. More importantly, use of
prescription opioids for more than 90 days increases the risk of progression towards addiction.164
A CDC Morbidity and Mortality Weekly Report published in July 2017 found that while
prescriptions for opioid medications have decreased since 2010, substantial variation in opioid
prescribing was observed at the county-level across the U.S.,165 demonstrating the need for
better application of guidance and standards around opioid prescribing practices.
In the first Commission meeting, the Commission heard from various medical societies about the
need to promote expanded implementation of the CDC opioid prescribing guideline. However,
while many professional organizations encourage use of the CDC guideline, it is important to
note the Commission received a substantial amount of correspondence from patients who
currently use opioid medications for legitimate medical reasons and are worried about the
guideline being too restrictive for their physicians to properly treat them. Clinicians have added
their concerns about the CDC guideline, including the time required to discuss alternative forms
of pain control, the difficulty in obtaining reimbursement for alternatives, how to address opioid
tapering, and concerns with the prescribing guideline for specific forms of pain. Furthermore, it
is important to point out that the CDC guideline is intended for primary care clinicians, who are
treating patients for chronic pain in outpatient settings, and more latitude in decision making
should be given to physicians that have specialized training in pain management. The
Commission also recognizes that the CDC guideline may not include specific recommendations
regarding patient education and informed consent.166 Patients are often ill-informed about the
risks of taking opioid analgesics and, therefore, are not able to balance the potential benefits of
opioid analgesics with the associated risks.
While progress has been made in training prescribers and fostering the adoption of prescribing
guidelines such as the CDC guideline, the Commission has learned that not all states have adopted
the guideline, not all physicians are aware of them, and sound opioid prescribing guidelines are
far from universally followed. For example, while the CDC guideline, as well as guidelines from
the VA and the Department of Defense (DOD), recommend clinicians use baseline and periodic
urine testing as part of a comprehensive plan to ensure the safe and effective use of opioid
therapies, not all states have placed sufficient emphasis upon the utility of medication screenings.
In the current crisis, drug testing not only allows providers to assess proper use of prescribed
medications in individual patients, but it would also be part of a broader solution in fighting the
opioid crisis, as it can provide a snapshot of controlled prescription drugs and illicit drugs
available in a community.
Consequently, the Commission recommended in the interim report that medical education and
prescriber education initiatives in proper opioid prescribing and risks of developing an SUD be
mandated (Appendix 3).
Stakeholders important to the adoption of prescribing guidelines include public and private
payers, medical and dental schools, physician and pharmacy groups, insurers, and health care
associations. Medical associations have developed courses for proper opioid prescribing practices,
with support from federal grants and made them available online for free.167,168,169,170 Federal
agencies have also compiled lists of courses in compliance with the CDC guideline.171,172 It is
imperative that all DEA registrants prescribing scheduled drugs develop proficiency in pain
management and opioid prescribing. In recognizing that OUD is associated with or preceded by
other SUDs, training on diagnosis and office-based treatment of addictions should also be
implemented for all stages of professional activity, including medical school, residency,
practicing clinicians, and all others legally permitted to prescribe scheduled drugs.
Given that the practice of medicine, including prescribing, is regulated primarily at the state level,
strategies for ensuring that prescribers are better informed and that patients are educated about the
relative risks and benefits of opioid analgesics should incorporate state governments.
Many states have acted to improve the safety of opioid prescribing. In July 2016, for example, 45
state governors signed the Compact to Fight Opioid Addiction173 under which signatories agreed
to update prescribing guidelines, require pain management continuing education for prescribers,
improve monitoring of providers prescribing opioids, and increase access to treatment and
recovery support services through state healthcare programs.174 In March 2016, Massachusetts
passed legislation175 limiting opioid analgesic prescriptions to a seven-day supply for first-time
adult users and for minors, mandating continuing medical education (CME) credits for effective
pain management, and requiring prescribers to check the state PDMP before writing a prescription
for a Schedule II or Schedule III narcotic.
Since January 2012, the State of Washington has required written treatment plans for use of
opioid analgesics and a written agreement between patients and prescribers outlining patient
responsibilities, including: taking the medications as prescribed; providing biological samples for
toxicology testing; releasing the agreement for treatment to local EDs, urgent care facilities, and
pharmacies; authorizing the prescriber to notify authorities if there is reason to believe the patient
has engaged in illegal activities; and, acknowledging that it is the patient's responsibility to
safeguard all medications and keep them in a secure location.176
A recent survey in Massachusetts found that 50% of respondents felt that painkillers are
prescribed too often or in larger doses than necessary; 47% felt that getting painkillers from those
who save them is too easy. Only 36% of respondents who had been prescribed an opioid were
informed of the addiction potential by their prescriber either before or while they were taking the
medication.177 In 2014, 4.4 million prescriptions for Schedule II or Schedule III opioids were
written for Massachusetts residents, resulting in the dispensation of 240 million pills or tablets.178
Together, these data point to the need to explore prescriber and patient education as a component
of any strategy to address the current opioid epidemic. A review of the curricula at the four
medical schools in Massachusetts revealed that, although they taught components of addiction
medicine, no uniform standard existed to ensure that all students were taught prevention and
management strategies for prescription drug misuse.
To fill this gap, Commission member Governor Baker and the Massachusetts Secretary of Health
and Human Services invited the deans of the states four medical schools to convene to develop a
common educational strategy for teaching safe and effective opioid-prescribing practices. With
leadership from the Department of Public Health and Massachusetts Medical Society, the deans
formed the Medical Education Working Group in 2015. This group reviewed the relevant
literature and current standards for treating SUDs and defined 10 core competencies for the
prevention and management of prescription drug misuse. The medical schools have incorporated
these competencies into their curricula and have committed to assessing students competence in
these areas. The members of the Medical Education Working Group have agreed to continue to
work together on key next steps, including connecting these competencies to those for residents,
equipping inter-professional teams to address prescription drug misuse, and developing materials
in pain management and opioid misuse for practicing physicians. This first-in-the-nation
partnership has yielded cross-institutional competencies that aim to address a public health
emergency in real time.
The following themes emerged from a literature review and from national and local standards for
treating SUDs. The core competencies are meant to enhance medical student training in primary,
secondary, and tertiary prevention strategies for prescription drug misuse and to provide students
with a strong foundation in prevention, identifying SUDs, and referring patients to appropriate
treatment. These competencies are designed to serve as a vital bridge between undergraduate
medical education and residency training.
1. Evaluate a patients pain using age, gender, and culturally appropriate evidence-based
methodologies.
2. Evaluate a patients risk for SUDs by using age, gender, and culturally appropriate
evidence-based communication skills and assessment methodologies, supplemented by
relevant available patient information, including but not limited to health records,
prescription dispensing records (e.g., the Prescription Drug Monitoring Program), drug
urine screenings, and screenings for commonly co-occurring psychiatric disorders
(especially depression, anxiety disorders, and posttraumatic stress disorder).
3. Identify and describe potential pharmacological and nonpharmacological treatment
options, including opioid and nonopioid pharmacological treatments for acute and chronic
pain management, along with patient communication and education regarding the risks
and benefits associated with each of these available treatment options.
Secondary prevention domain: Treating patients at risk for SUDs (engaging patients in
safe, informed, and patient-centered treatment planning)
4. Describe SUD treatment options, including MAT, as well as demonstrate the ability to
appropriately refer patients to addiction medicine specialists and treatment programs for
both relapse prevention and co-occurring psychiatric disorders.
5. Prepare evidence-based and patient-centered pain management and SUD treatment plans
for patients with acute and chronic pain with special attention to safe prescribing and
recognizing patients displaying signs of aberrant prescription use behaviors.
6. Demonstrate the foundational skills in patient-centered counseling and behavior change in
the context of a patient encounter, consistent with evidence-based techniques.
Tertiary prevention domain: Managing SUDs as chronic diseases (eliminating stigma
and building awareness of social determinants)
7. Recognize the risk factors for, and signs of, opioid overdose and demonstrate the correct
use of naloxone rescue.
8. Recognize SUDs as a chronic disease by effectively applying a chronic disease model in
the ongoing assessment and management of the patient.
9. Recognize their own and societal stigmatization and biases against individuals with SUDs
and associated evidence-based MAT
10. Identify and incorporate relevant data regarding social determinants of health into
treatment planning for SUDs.
Integrating the core competencies for the prevention and management of prescription drug misuse
with any related competencies for residents is critical to ensuring that medical students are
required to maintain and expand these skills as they enter residency training. Furthermore, the
group recognized the need to expand inter-professional education opportunities designed to better
equip collaborative teams for primary, secondary, and tertiary prevention of OUDs. As other
practitioners, including nurses, pharmacists, dentists, and mental health providers, among others,
also contribute to the provision of care, they too must demonstrate competence in this area.
Finally, the group recognized the need for continuing medical education materials for current
prescribers.
The level of urgency is greater than ever to develop creative solutions based on exploiting modern
data mining and communication proficiencies. A more rational approach is to develop detailed
and specific guidance for clinicians treating specific manifestations of pain. With modern data
analytical techniques capable of interrogating vast prescribing databases, it is feasible to identify
current patterns of opioid prescribing for specific conditions, recommend changes in practice
patterns based on specific pain sources and medical specialties, and create active programs to
educate practitioners on these recommendations. Combined with data from PDMPs, a simple
electronic printout conceivably can assist in guiding a physicians decision on prescribing opioids
or alternatives for pain management. Decisions on pain management can be fortified with
additional information on a patients physical and mental health status, as the complex causes of
pain can arise from a confluence of biological, psychological, and social factors.
To advance this goal, providers need to be informed about suitable prescribing practices for
opioids, a class of drugs which confer benefit, as well as high risk. Pharmacoepidemiology
research can facilitate improvements to the CDC guideline by initially defining existing patterns
of opioid use and then developing condition-specific guidelines on optimal opioid dosing.179,180
To create a more useful foundation for interventions to reduce improper use of prescription
opioids, much more needs to be known of existing patterns of prescription for specific
conditions, including diagnosis, drug choice, dose, amount prescribed, and physician and patient
characteristics. This work would draw on the extensive experience of pharmacoepidemiological
analysis,181 as well as extensive population-based datasets from both the public and private
sector.182 These studies will help to define which specific problems of opioid overuse are most
prevalent in which settings in order to better focus public and private interventions on the areas
of greatest need, in terms of clinical conditions, provider types, patient characteristics, and
practice settings. The second and more important goal is to develop condition-specific guidelines
on optimal opioid dosing. While CDC and other groups have set forth general guidelines on the
principles of pain management, and some states have established uniform limits on the maximum
number of tablets or capsules that can be prescribed for a first opioid prescription, clinicians need
more detailed and specific guidance on drug choice, dose, and quantity to be dispensed in
treating specific common conditions. Data analytics can build on the overall guidance documents
prepared for pain management in general by: (a) reviewing the entire existing literature on
evidence concerning condition-specific pain therapy, including recommended agents, doses, and
quantities; (b) convening several expert clinician panels to generate condition-specific guidelines
for managing the most common indications for pain medications; and (c) transforming that
information into concise, clinically relevant, and actionable recommendations that can be
disseminated to practitioners.
Pharmacists are under pressure to continue filling prescriptions from irresponsible providers. A
recent study of Wisconsin pharmacists found that a not insignificant minority did not understand
what is legitimate practice under federal and state laws about evaluating the legitimacy of a
controlled substance prescription also known as corresponding responsibility. Further, 36% of
6. The Commission recommends HHS, the Department of Labor (DOL), VA/DOD, FDA,
and ONDCP work with stakeholders to develop model statutes, regulations, and policies
that ensure informed patient consent prior to an opioid prescription for chronic pain.
Patients need to understand the risks, benefits and alternatives to taking opioids. This is
not the standard today.
7. The Commission recommends that HHS coordinate the development of a national
curriculum and standard of care for opioid prescribers. An updated set of guidelines
for prescription pain medications should be established by an expert committee
composed of various specialty practices to supplement the CDC guideline that are
specifically targeted to primary care physicians.
8. The Commission recommends that federal agencies work to collect participation data.
Data on prescribing patterns should be matched with participation in continuing
medical education data to determine program effectiveness and such analytics shared
with clinicians and stakeholders such as state licensing boards.
9. The Commission recommends that the Administration develop a model training
program to be disseminated to all levels of medical education (including all prescribers)
on screening for substance use and mental health status to identify at risk patients.
10. The Commission recommends the Administration work with Congress to amend the
Controlled Substances Act to allow the DEA to require that all prescribers desiring to
be relicensed to prescribe opioids show participation in an approved continuing medical
education program on opioid prescribing.
11. The Commission recommends that HHS, DOJ/DEA, ONDCP, and pharmacy
associations train pharmacists on best practices to evaluate legitimacy of opioid
prescriptions, and not penalize pharmacists for denying inappropriate prescriptions.
Today, 49 states and the District of Columbia currently have legislation authorizing the operation
of PDMPs in their jurisdictions. However, except in states with mandated PDMP use, providers
who see patients and prescribe opioids, or have patients affected by opioids, dont routinely
register for or use PDMPs. The national median PDMP registration rate among licensed
prescribers is only 35%, per a report in the Journal of the American Medical Association
published in 2015. Furthermore, a study by the Johns Hopkins Bloomberg School of Public
Health found that patient history was not checked via a PDMP database by the prescriber in 86%
of prescriptions for opioids written in 2015.
The Federal Government should leverage mechanisms to facilitate PDMP use. Congress should
pass and the President should sign the Prescription Drug Monitoring (PDMP) Act of 2017, which
would mandate the creation and use of PDMPs by states who receive federal funding to fight the
opioid crisis. This Act would impose strict PDMP requirements, such as a 24-hour reporting
requirement after dispensing a controlled substance, further centralize prescribing data, and
would help to facilitate data sharing across the states.
12. The Commission recommends the Administration's support of the Prescription Drug
Monitoring (PDMP) Act to mandate states that receive grant funds to comply with
PDMP requirements, including data sharing. This Act directs DOJ to fund the
establishment and maintenance of a data-sharing hub.
13. The Commission recommends federal agencies mandate PDMP checks, and consider
amending requirements under the Emergency Medical Treatment and Labor Act
(EMTALA), which requires hospitals to screen and stabilize patients in an emergency
department, regardless of insurance status or ability to pay.
Providers often resist using PDMPs because these systems are not well integrated into the
electronic health records (EHR) systems they currently use in practice, and for other reasons,
including inadequate training on the use and complexity of some PDMP software programs. The
Heller School at Brandeis University recommends simplifying the method of access to PDMPs
for providers by integrating PDMP data into health information exchanges, increasing the
likelihood that prescription history information will be used in clinical decision-making.
Furthermore, many EHR systems also integrate electronic prescribing of controlled substances
(EPCS). The American Medical Association (AMA) and the American College of Physicians
both recommend EPCS as one of the top tactics to combat opioid abuse, as eliminating paper
prescriptions will improve accuracy, reduce diversion and fraud, as well as improve data quality
to PDMPs. However, only the States of Maine and New York have mandated the use of
electronic prescribing for controlled substances (Minnesota has mandated e-prescribing since
2011, but no enforcement mechanism exists), and these states are using Medicaid reimbursement
rates to incentivize providers to use EPCS. Other states have followed suit; Virginia passed
legislation mandating statewide EPCS to take effect in 2020. More recently, Commission
member Governor Cooper signed the Strengthen Opioid Misuse Prevention (STOP) Act which,
as of July 1, 2017, requires electronic prescribing of certain schedule II and III controlled
substances, including opioid medications, in North Carolina. Practitioner ability to electronically
prescribe controlled substances in the United States is currently governed by an interim final
rule, which would benefit from a revision so practitioners can take advantage of modern
technology that would make registration and use of this service easier.
Practitioners are also hesitant to use PDMPs because they often do not know what to do when
they identify patients with a potential SUD. Physicians and other health professionals often do
not have adequate training in SUDs to assess patients and may need coaching on how to
effectively address the issue of a potential SUD. This is especially relevant if the PDMP
indicates a high-risk patient requiring tapering, alternatives for pain management, and specialty
treatment for OUD. Inadequate patient support or treatment may compromise the value of the
PDMP,184 and promote a transition to illicit opioids if prescription opioids are eliminated. In
addition, providers are typically pressed for time and often complain that if a patient is flagged
by a PDMP they are either ill-equipped to screen for an SUD and/or unable to make a successful
referral to specialty SUD treatment programs. ASAM strongly recommends that prescribers be
trained in engagement strategies that result in linking patients to treatment when indicated.
Integrated decision support tools, such as the screening tools used in SBIRT interventions, could
also help practitioners make a quick determination about the likelihood of a SUD and to
recommend appropriate specialty care or an appropriate specialty treatment provider at which to
obtain an assessment.
There are a number of new and innovative tools for providers to determine which patients are at
risk of adverse effects from prescription opioids, including accidental overdose or development
of an SUD. Some are used at the provider level and some analytic tools are used at the payer
level to flag certain patients for follow-up or interventions.
14. The Commission recommends that PDMP data integration with electronic health
records, overdose episodes, and SUD-related decision support tools for providers is
necessary to increase effectiveness.
15. The Commission recommends ONDCP and DEA increase electronic prescribing to
prevent diversion and forgery. The DEA should revise regulations regarding electronic
prescribing for controlled substances.
Organizations such as the Association of State and Territorial Health Officials (ASTHO) and
Palantir recommend that multiple data sources should be integrated, accessible, and up-to-date in
PDMPs to rapidly predict and detect outbreak hot spots and disease clusters for both public
health and law enforcement purposes.185 Medical providers would benefit from knowing if
patients overdosed so they can adjust their treatment, but currently those records do not flow
back to primary care from emergency rooms or emergency responders because, in many medical
settings, the differing EHR systems are not sufficiently interoperable. Patient privacy laws, while
well-meaning, can also hinder the ability to share this information between medical providers.
However, the Department of Transportation (DOT) maintains a database of EMT responses for
overdoses that could inform PDMPs about patients level of risk and provide better decision-
making tools for the prescriber.
16. The Commission recommends that the Federal Government work with states to remove
legal barriers and ensure PDMPs incorporate available overdose/naloxone deployment
data, including the Department of Transportations (DOT) Emergency Medical
Technician (EMT) overdose database. It is necessary to have overdose data/naloxone
deployment data in the PDMP to allow users of the PDMP to assist patients.
Prescription Take-Back Programs and Drug Disposal
The National Prescription Drug Take Back Day, organized by the DEA with state and local
partners, provides communities a safe and convenient way to dispose of their unneeded
prescription drugs, while educating the public about the dangers for the public of abuse and
misuse. Providers wrote nearly a quarter of a billion opioid prescriptions in 2013. This is enough
for every American adult to have a bottle of prescription opioids.186 Many misusers of
prescription drugs have indicated they received prescriptions from their family and friends
medicine cabinets.187
DEAs Take Back Day, which is held twice a year, provides an opportunity for communities to
dispose of their unneeded prescriptions. In addition, these events are often community driven and
offers the public a venue to host community health fairs and provide information about drug
screening and treatment services. Offering drug screening and treatment information and
resources during Take Back events encourages friends and family of loved ones with a substance
abuse problem to obtain information and support on a convenient walk in basis. There is also a
need to leverage resources by collaborating with other health professionals that offer
comprehensive health and substance use services.
States have also established year-round take-back programs in partnership with community
stakeholders and local law enforcement agencies. North Carolinas Operation Medicine Drop is
the largest take-back program in the U.S., and has collected nearly 89.2 million pills at more than
2000 events since 2010.
There is an opportunity to increase efforts by encouraging hospitals/clinics with onsite
pharmacies and retail pharmacies to become authorized collectors. Authorized collectors provide
a year-round opportunity for the public to properly dispose of their unused prescriptions. Onsite
and retail pharmacies have a tremendous opportunity to aid in increasing collection rates by
considering incentivizing the public to drop off their unneeded prescriptions by offering store
rebates.
In addition, the Federal Government supported the development of drug deactivation bags to
allow the safe disposal of old prescription opioids. Drug deactivation bags would be particularly
useful in rural areas where an authorized collector may not be nearby. The use of such bags
would complement Take Back Day events and give consumers more options. Furthermore, the
Federal Government could explore a potential partnership with onsite and retail pharmacies to
fund and include a drug deactivation bag with opioid prescriptions. This would provide an
opportune moment at the time of drug dispensing to educate the patient on and encourage safe
drug disposal.
17. The Commission recommends community-based stakeholders utilize Take Back Day to
inform the public about drug screening and treatment services. The Commission
encourages more hospitals/clinics and retail pharmacies to become year-round
authorized collectors and explore the use of drug deactivation bags.
Pain Level as an HHS Evaluation Criteria
As a condition of full reimbursement of hospitals, the Centers for Medicare and Medicaid
Services (CMS) requires that hospitals randomly survey discharged inpatients using the post-
hospitalization survey the Hospital Consumer Assessment of Healthcare Providers and Systems
(HCAHPS).188 While hospitals must survey only a small percent of patients and response rates
are not high (~18%), some elect to also use email to survey every patient and use these responses
to improve their own internal processes. This information is reported as part of the program for
hospital ratings, Hospital Compare,189 which offers a public data tool for prospective patients.
The tool allows comparison of hospitals across the US on these and other metrics related to
patient outcome. During Affordable Care Act (ACA) implementation, the survey became part of
how CMS calculates the VBP Incentive, which gives hospitals maximal reimbursement when
they reach certain targets. HHS previously included the pain question response information in
calculations of incentive payments, but in 2017, CMS announced they would stop including the
questions in the VBP program calculation. HHSs stated reason for removing the pain questions
from the VBP calculation was to ensure there would not be any financial incentive or pressure to
prescribe.190 HHS has removed the former pain management questions and replaced them with
pain management communication questions instead. Moving forward, they intend to continue to
include them in HCAHPS.
However, providers and provider associations have expressed they are being required to treat
pain with opioids to maintain high ratings. Recent published research since has shown that those
with new opioid prescriptions post-discharge are more likely to report their pain was always well
managed suggesting that savvy providers have figured out that opioids are a way to manipulate
satisfaction.191 This study also found a new opioid claim within seven days of discharge was
likely to be associated with an opioid claim 90 days post-discharge in Medicare.192 Finally, other
studies showed ratings of orthopedists performing knee and hip replacement were higher in
patients reporting better pain control and orthopedist ratings and sometimes hospital ratings were
also affected.193,194 The research suggests that the current approach to pain treatment in the
hospital that meets the highest level of response is iatrogenic for ongoing (90-day post-hospital)
opioid use.
18. The Commission recommends that CMS remove pain survey questions entirely on
patient satisfaction surveys, so that providers are never incentivized for offering opioids
to raise their survey score. ONDCP and HHS should establish a policy to prevent
hospital administrators from using patient ratings from CMS surveys improperly.
Reimbursement for Non-Opioid Pain Treatments
A key contributor to the opioid epidemic has been the excess prescribing of opioids for common
pain complaints and for postsurgical pain. Although in some conditions, behavioral programs,
acupuncture, chiropractic, surgery, as well as FDA-approved multimodal pain strategies have
been proven to reduce the use of opioids, while providing effective pain management, current
CMS reimbursement policies, as well as health insurance providers and other payers, create
barriers to the adoption of these strategies. In the third Commission meeting, the Commission
heard from several innovative pain management and pharmaceutical companies about the need
for proper reimbursement of non-opioid pain medications to increase uptake among healthcare
providers and limit the use of opioids. For example, the current CMS payment policy for
supplies related to surgical procedures creates unintended incentives for those that prescribe
opioid medications to patients for postsurgical pain instead of administering non-opioid pain
medications. Under current policies, CMS provides one all-inclusive bundled payment to
hospitals for all surgical supplies, which includes hospital administered drug products intended
to manage patients postsurgical pain. This policy results in the hospitals receiving the same
fixed fee from Medicare whether the surgeon administers a non-opioid medication or not. Any
costs the hospital incurs for creating and administering a multimodal pain management strategy
essentially get deducted from its fixed fee payment. Thus, purchasing and administering a non-
opioid medication in the operating room increases the hospitals expenses without a
corresponding increase in reimbursement payment. Dispensing and writing a prescription for
postsurgical opioids, on the other hand, costs the hospital very little, especially since most
opioids are generic. Inadequate reimbursement significantly hampers providers ability to utilize
non-opioid treatment for postsurgical pain.
A broader range of pain management and treatment services including alternatives to opioids,
physical therapy, computerized pain management educational programming, PDMP checking,
evidence-based behavioral health treatment, tapering off opioids, and drug testing to confirm
adherence should be adequately reimbursed by payers, including CMS.
19. The Commission recommends CMS review and modify rate-setting policies that
discourage the use of non-opioid treatments for pain, such as certain bundled payments
that make alternative treatment options cost prohibitive for hospitals and doctors,
particularly those options for treating immediate post-surgical pain.
Reducing and Addressing the Availability of Illicit Opioids
Along with reducing the supply of unnecessary prescription opioids, a major component of
prevention is reducing the number of illicit opioids available on the streets, such as heroin, illicit
fentanyl and fentanyl analogues, or diverted prescription opioids. In the Commissions interim
report, the Commission recommended prioritizing funding and manpower to federal law
enforcement agencies to develop fentanyl detection sensors, to disseminate them to federal, state,
local, and tribal law enforcement agencies, and to support federal legislation to stop synthetic
opioids from coming into the country through the U.S. Postal Service (Appendix 3). The
Commission believes the recommendations outlined below will further address the availability of
and staunch the flow of existing and newly emerging dangerous opioids crossing the border into
our country.
national trends. It is imperative that all levels of government develop a set of core public health
and public safety indicators that can be standardized, collected, analyzed, and shared to inform
local, regional, and national prevention, education, outreach, treatment, and enforcement
initiatives.
The Federal Government has made considerable investments in capabilities that facilitate
collaboration among federal, state, and local agencies to enhance our Nations ability to address
various threats affecting our communities. For example, the CDC has provided federal grant
funding to select states to improve prevention and response efforts by supporting more timely
public health data collection, disseminating public health surveillance findings to key
stakeholders within states, and sharing data with the CDC to support improved multi-state public
health surveillance. On the public safety side, the existing models of public health and public
safety information sharing have largely been supported by federal grant programs and technical
assistance administered through the DOJs Bureau of Justice Assistance (BJA), and the CDC.
Improved coordination among federal departments and agencies related to grant funding and
technical assistance activities will expand models of public health, behavioral health, and public
safety information sharing and collaboration at the state and local level.
Likewise, states have leveraged Department of Homeland Security (DHS) preparedness grant
funding to effectively implement, in collaboration with federal partners, a decentralized and
coordinated information sharing environment to identify, analyze, and share public safety
information across all levels of government and first responder disciplines. Significant strides
have also been made to enhance the Nations capacity to collect, share, and analyze public safety
information, and disseminate actionable and strategic intelligence to key stakeholders from all
levels of government. A critical component of the national response to the 9/11 terrorist attacks
was the development of a national-level, decentralized, and coordinated information sharing
environment that prioritizes information security and protects individual privacy, civil rights, and
civil liberties. State and major urban area fusion centers, the High Intensity Drug Trafficking
Areas (HIDTA) Program, and Regional Information Sharing Systems (RISS) Centers are some
of the key field-based information sharing, analytic, and investigative entities that leverage this
capability to enable interjurisdictional and multidisciplinary information sharing, and facilitate
collaboration among federal, state, and local public safety partners to address both local and
national threats. It is sensible to evaluate how investments in the national information sharing
environment could be used to support public health and public safety information sharing and
collaboration at all levels of government.
At the state and local levels, successful frameworks for public health and public safety
collaboration are expanding. Several states have developed drug monitoring initiatives (DMIs)
and overdose fatality review teams, while New York City has developed the RxStat initiative.
These efforts integrate various public safety and public health data sets to include drug overdose
deaths, non-fatal overdoses, naloxone administrations, prescriber data, drug arrests, drug
seizures, and laboratory results. The analysis of these data enables public safety and public health
stakeholders to develop and implement prevention, education, outreach, treatment, and
enforcement initiatives that protect public safety and reduce drug use and its consequences.
These data can be used to develop coordinated risk-reduction strategies tailored to local
communities or specific regions.
20. The Commission recommends a federal effort to strengthen data collection activities
enabling real-time surveillance of the opioid crisis at the national, state, local, and tribal
levels.
In the United States, medicolegal death investigation (MDI) is conducted via a county-based
system of medical examiners and coroners (ME/Cs). There are no national standards for
conducting MDI in drug overdose cases; including when to investigate a death, any requisite
accreditation of ME/C offices and the certification of their investigators, protocols for which
drugs to test for and at what cut-off levels, the possibility of suicide, or how or to whom to report
findings. The absence of shared standards and procedures prohibits the accurate and timely
identification and prioritization of drug threats and the evaluation of the effectiveness of public
health and safety policies implemented to abate them. The DOJ and the National Institute of
Standards and Technology are currently leading an effort to standardize the process for forensic
investigations. Consistency in the investigation and reporting procedures following fatal and
nonfatal drug overdose events will permit improvements to the timeliness and completeness of
mortality reporting statistics and is necessary to make better and more efficient use of limited
state and federal funds.
21. The Commission recommends the Federal Government work with the states to develop
and implement standardized rigorous drug testing procedures, forensic methods, and
use of appropriate toxicology instrumentation in the investigation of drug-related
deaths. We do not have sufficiently accurate and systematic data from medical
examiners around the country to determine overdose deaths, both in their cause and the
actual number of deaths.
Estimates of the extent of the opioid epidemic in the United States may be underestimated due to
inadequate systems reporting information on the number, location, and degree of opioid
consequences. Surveys of chronic drug users and morbidity information could provide timely and
in-depth insights into the opioid crises, but were defunded from the budgets of federal agencies.
Current data systems do provide some level of measurement, but miss some important aspects of the
opioid epidemic. Restoration of funding for these terminated programs is needed to obtain more
detailed information on the opioid epidemic.
The unique aspects of opioid drugs exacerbate the issues of monitoring the misuse problem,
unlike other illicit drugs such as marijuana, cocaine, or methamphetamine. Cocaine, for example,
has been a drug of consequence for decades, is abused by millions of people in the United States,
and has limited variations in composition. Data systems monitoring the extent of the cocaine
problem have been standardized and institutionalized. Opioids, on the other hand, consist of
many drug varieties, including prescription pain medications, heroin, and most recently, illicitly-
manufactured fentanyl. Millions of people misuse prescription pain medications, but only a small
fraction of that number abuse heroin. These fewer numbers present a challenge for estimating the
prevalence of use by the standard federal survey.
For example, the NSDUH, a federal statistical survey of about 70,000 Americans annually (cited
often throughout this report), estimated that 600,000 people used heroin in 2010.195 A study
conducted by the RAND Corporation on illicit drug expenditures in America estimated the
number of heroin users in 2010 to be closer to 1.5 million.196 This dramatic discrepancy has been
discussed by the press.197 Illicitly-produced fentanyl, another rapidly growing component of the
opioid epidemic is not even routinely tracked by surveys such as NSDUH or drug seizure data
systems.
Two discontinued data systems that would provide enhanced fidelity to measuring the extent of
the opioid crisis are the Arrestee Drug Abuse Monitoring (ADAM) Program and the Drug Abuse
Warning Network (DAWN). ADAM was a survey of current local high-risk arrestees in jails
accompanied by a urinalysis test. Until its termination by the National Institute of Justice in
2003, over 30 jails in cities throughout the country were sampled and tested. These data would
provide timely, geo-specific data on opioid use, supported with a confirmatory lab test. The lab
analysis could also be adjusted to test for any new opioids appearing in the U.S. market. DAWN
was a tabulation of drug mentions in hospital emergency rooms. SAMHSA funded the DAWN
program until 2011. These morbidity data would provide a sentinel system, alerting decision
makers of the consequences of opioid use before more serious overdoses would occur.
Existing data collection systems, including the major surveys, like the NSDUH and the
Monitoring the Future study, need to be maintained and improved, and the data gaps need to be
filled and revitalized using such novel approaches such as testing wastewater in highly
circumscribed regions (e.g. a few blocks) for estimating drug metabolites. This innovative
system has already collected biological specimens from high-risk populations for early
indications of the changing drug landscape. Population-level data from toxicology screening can
also provide a snapshot of drug use and misuse. Local information is essential to complement
national data in informing public health and public safety responses to the opioid epidemic.
The possibility of a behavioral health surveillance system at sentinel sites across the country
exists for 12+ sites currently under NIDA funding and additional resources have recently been
awarded by CDC to 44 states and the District of Columbia to include better tracking of opioid-
related overdoses. There is a need for an integrated system that, across the country, can track
prevalence rates, treatment modalities, and comorbidities with other illnesses in real-time.
Recognizing that there is variability across the United States, these surveillance or sentinel sites
can be established for a multitude of local areas across the country.
22. The Commission recommends reinstituting the Arrestee Drug Abuse Monitoring
(ADAM) program and the Drug Abuse Warning Network (DAWN) to improve data
collection and provide resources for other promising surveillance systems.
New Hampshire law defines the term fentanyl class drug with reference to a listing of specific
substances. N.H. Rev. Stat. 318-B:1(XI-a.). These drugs are assigned the same criminal
penalties as are heroin or crack cocaine. N.H. Rev. Stat. 318-B:26.
While states consider laws that aim to reduce the supply of fentanyl, including harsher penalties
for smaller quantities, given the potency, it is also important to consider whether users, who buy
fentanyl unknowingly, could be unnecessarily punished for distribution. For individuals with
OUD who are arrested with fentanyl, other factors beyond quantity should be considered to
determine possession for personal use versus distribution.
23. The Commission recommends the enhancement of federal sentencing penalties for the
trafficking of fentanyl and fentanyl analogues.
As mentioned above, illicit fentanyl and fentanyl analogues are increasingly being pressed into
counterfeit prescription opioid pills, often mimicking the appearance of commonly prescribed
opioid pain killers such as OxyContin, by Drug Trafficking Organizations (DTOs) and smuggled
into the United States in large quantities. While fentanyl seizures are most typically in a powder,
salt, or rock-like form, DEAs El Paso Intelligence Center (EPIC) reports an increase in the
number of pills seized. In 2016 an estimated 15,632 domestically seized tablets and capsules
were identified by DEA forensic laboratories as containing some amount of fentanyl or fentanyl
analogues with or without other illicit drugs and non-narcotic substances. This represents
approximately 16 times the number of fentanyl tablets and capsules analyzed by DEAs
laboratories in 2014.198
Fentanyl in pill form has enabled the development of a more diverse user population that is
skewing younger and perhaps more opioid nave. Moreover, the prototypical experienced
intravenous drug user of previous illicit opioid crises has been joined by those who believe they
are buying off-market prescription opioids, but are in fact buying fentanyl pressed into pill form.
Furthermore, the online marketplace and cryptocurrencies have empowered a democratization
of the drug trade, where the hierarchical DTOs the United States has effectively confronted for
the past several decades no longer have a monopoly on supplying drugs. Rather, individuals can
simply go online to one of many internet drug marketplaces and purchase illicit drugs for their
own personal use or for further sale on a limited scale, creating a constellation of micro-
networks across the country that are difficult to locate and nearly impossible to dismantle. The
ability to easily purchase drugs like fentanyl online, which are subsequently shipped in a manner
and at volumes that make them hard to detect, demonstrates a new pathway for these potent
drugs to enter the domestic supply chain. This change carries enormous implications for the law
enforcement and justice communities, and requires a framework of relationships, laws and
regulations, and procedures to deal with an environment of drug trafficking and use the nation is
just beginning to see.
The growing internet drug market, particularly for fentanyl and fentanyl analogues, is a clearly
identified critical vulnerability in interrupting the supply of these drugs into the United States.
Since the 2013 closing of the first well-known cryptomarket, Silk-Road 1.0, both the clear and
the dark web have further expanded the illicit drug market, allowing individuals to purchase
dangerous drugs directly from their manufacturers instead of through established trafficking
organizations. Internet sales of fentanyl and other synthetic substances has evolved into a direct
to consumer market generating large revenues. A Carnegie Mellon University study estimated
that revenues from online illicit drug sales increased from between $15-17 million in 2012 to
$150-$180 million in 2015.199 The recent multi-agency and international effort, led by the DOJ,
which resulted in the takedown of the Alphabay marketplace was a monumental step forward in
this effort.
The dynamics of synthetic drugs and their availability online has the potential to permanently
change the drug market. The Federal Government currently lacks a sustained, coordinated, and
well-resourced effort to attack the illicit drug online purchase infrastructure to identify and target
the network of actors involved, and limit the amount of fentanyl and fentanyl analogues entering
the United States.
24. The Commission recommends that federal law enforcement agencies expressly target
Drug Trafficking Organizations and other individuals who produce and sell counterfeit
pills, including through the internet.
The importation of tableting machines (pill presses) is regulated by DEA. DEA has recently
enhanced importation regulations by replacing paper reporting with an electronic process.
However, the active use of pill presses remains unregulated. While DEA currently can inspect a
registrants use of controlled substances in their usable form to verify they are well stored and
used for their stated registered purposes, the DEA currently cannot inspect pill presses to verify
that equipment is not being used to produce counterfeit drugs.
25. The Commission recommends that the Administration work with Congress to amend
the law to give the DEA the authority to regulate the use of pill presses/tableting
machines with requirements for the maintenance of records, inspections for verifying
location and stated use, and security provisions.
manual, requiring CBP officers to sort through large volumes of parcels to identify potential
shipments of concern. CBP screens all international mail parcels for radiological threats, x-rays
all international mail packages presented by USPS, and physically examines those deemed high-
risk.
The USPS processed over 275 million international inbound mailings in FY 2016. Of those
items, there were over ten million international express mail items and over four million air and
surface parcels. In FY 2016, the USPIS initiated 2,439 cases involving drug trafficking and made
1,850 arrests which resulted in 1,571 convictions. Additionally, inspectors seized illegal assets
valued at approximately $23.5 million, to include 89 pounds of heroin, 13,968 Oxycodone
tablets, and fentanyl-family synthetic opioids on 36 occasions. In these cases, USPIS utilized
intelligence derived from drug seizures, international partnerships, and strong relationships with
federal, state, local and tribal law enforcement agencies.
Because of the increased threat of fentanyl, and the interagency focus on disrupting the fentanyl
supply chain, CBP undertook a pilot program to train canines to detect fentanyl. Although
training canines to detect synthetic drugs is a difficult undertaking, the CBP has already trained
and fielded canines and placed them in critical locations in the United States to screen incoming
parcels to indicate the presence of fentanyl and other synthetic opioids. Canine screening and
detection, complemented by the deliberate targeting of shippers associated with fentanyl
trafficking, has the potential to increase the likelihood that those containing illicit opioids are
seized and removed from the supply chain.
The incredibly high volume of mail, fentanyls ability to be shipped in very small quantities, a
low number of available automated detection systems, and the relatively small number of trained
canines make intercepting fentanyl and fentanyl analogues at IMFs monumentally difficult.
26. The Commission recommends U.S. Customs and Border Protection (CBP) and the U.S.
Postal Inspection Service (USPIS) use additional technologies and drug detection
canines to expand efforts to intercept fentanyl (and other synthetic opioids) in envelopes
and packages at international mail processing distribution centers.
The sheer volume of international mail and IMF infrastructure make interdiction efforts focused
on illicit opioids and other drugs a monumental task. One method to address this issue is the
increased use of Advanced Electronic Data (AED). Federal regulation requires express package
operators to transmit AED prior to package arrival in the United States. AED consists of
electronic data about the particulars of each shipment such as sender/receipt names and
addresses, contents and quantity. AEDs primary use is for advanced targeting for CBP
inspections efforts. With AED, CBP can advance-target incoming shipments for additional
examination based upon intelligence, prior violations, and other risk factors.
Over 90% of inbound international mail is sent from USPSs top-volume trading partners. USPS
now receives AED on inbound packages from 20 countries, including China. International mail
services are not required by International law to transmit parcel information prior to arrival in the
United States and many do not have the capability to do so even if required. However,
international law requires nations establishing such requirements to ensure they can be met by all
nations.
To this end, the Commission recommends support of the Synthetics Trafficking and Overdose
Prevention (STOP) Act of 2016 or the STOP ACT of 2016, which amends the Tariff Act of 1930
to make the Postmaster General the importer of record for non-letter class mail imported into the
United States. The bill amends the Consolidated Omnibus Budget Reconciliation Act of 1985 to
impose a duty of $1 on each item of non-letter class mail imported into the United States. The
bill amends the Trade Act of 2002 to direct the Department of the Treasury to require the
Postmaster General to provide for AED transmission to CBP of certain information on non-letter
class mail imported into the United States.
27. The Commission recommends Congress and the Federal Government use advanced
electronic data on international shipments from high-risk areas to identify international
suppliers and their U.S.-based distributors.
28. The Commission recommends support of the Synthetics Trafficking and Overdose
Prevention (STOP) Act and recommends the Federal Government work with the
international community to implement the STOP Act in accordance with international
laws and treaties.
DEA reports that diversion of licit fentanyl, either from theft or fraud, currently accounts for
about 2-3% of fentanyl-related overdose deaths. However, as government agencies and
international partners achieve success disrupting the illicit fentanyl supply chain, there is high
confidence that the licit fentanyl, as well as other prescription opioids, stock and supply chain
will experience an increased risk of diversion.
In 2011, Commission member Florida Attorney General Bondi fought for the passage of House
Bill 7095 Florida Legislature, which aimed to regulate pill mills by combating prescription
drug diversion. Specific features of Floridas legislation included adding new criminal penalties,
requiring wholesale distributors to credential customers and report on distribution of controlled
substances, as well as funding state Regional Drug Enforcement Strike Forces. Within 18 months
of the legislation passage, Florida achieved the largest-by an order of several magnitude-year-on-
year recorded drops in prescription drug overdose deaths in the nation.
At any point in the manufacturing, distribution, and prescription process, fentanyl, like other
prescription opioids, can be diverted for illicit use. The nation should re-examine its current
procedures to track the licit supply chain to prevent the diversion of precursor chemicals,
partially processed product, and finished material in manufacturing facilities. Additionally, there
are few mechanisms to track fentanyl and prescription opioid diversion once the drug is issued
by a medical professional to a patient for consumption. One such method could be a requirement
for the recipients and users of legally prescribed fentanyl to provide proof, such as empty
transdermal patch envelopes or lollipop sticks to a pharmacist before receiving their refills.
Another control initiative could be placing restrictions on dispensing fentanyl through the mail,
or requiring that packages containing fentanyl or other opioids must be signed for by the
recipient.
The DEA must be able to successfully disrupt the diversion of prescription opioid at any and all
points in the supply chain.
30. The Commission recommends the White House develop a national outreach plan for
the Fentanyl Safety Recommendations for First Responders. Federal departments and
agencies should partner with Governors and state fusion centers to develop and
standardize data collection, analytics, and information-sharing related to first
responder opioid-intoxication incidents.
Opioid Addiction Treatment, Overdose Reversal, and
Recovery
Drug Addiction Treatment Services
In the interim report, the Commission reported that the use of MAT has been associated with
reduced overdose deaths, retention of persons in treatment, decreased heroin use, reduced
relapse, and prevention of the spread of infectious disease. The Commission recommended
several steps to increase the use of and access to all forms of SUD treatment, including MAT for
SUDs, including removing the federal Institutes of Mental Diseases (IMD) exclusion within the
Medicaid program, establishing a federal incentive to enhance access to MAT, and requiring
regulators to take enforcement action against health plans that violate the Mental Health Parity
and Addiction Equity Act (MHPAEA) (Appendix 3). The Commission also expressed support
for the Overdose Prevention and Patient Safety Act/Protecting Jessica Grubbs Legacy Act, and
the need to update patient privacy laws, such as 42 CFR Part 2, to ensure that information about
SUDs are made available to medical professionals treating and prescribing medication to
patients. Building off the previous recommendations, the Commission supports implementation
of the steps outlined below to remove additional barriers and further improve access to and
quality of drug addiction treatment services across the nation.
31. The Commission recommends HHS, CMS, the Substance Abuse and Mental Health
Services Administration (SAMHSA), the VA, and other federal agencies incorporate
quality measures that address addiction screenings and treatment referrals. There is a
great need to ensure that health care providers are screening for SUDs and know how
to appropriately counsel, or refer a patient. HHS should review the scientific evidence
on the latest OUD and SUD treatment options and collaborate with the U.S. Preventive
Services Task Force (USPSTF) on provider recommendations.
32. The Commission recommends the adoption of process, outcome, and prognostic
measures of treatment services as presented by the National Outcome Measurement 210
and the American Society of Addiction Medicine (ASAM).211 Addiction is a chronic
relapsing disease of the brain which affects multiple aspects of a person's life.
Providers, practitioners, and funders often face challenges in helping individuals
achieve positive long-term outcomes without relapse.
33. The Commission recommends HHS/CMS, the Indian Health Service (IHS), Tricare, the
DEA, and the VA remove reimbursement and policy barriers to SUD treatment,
including those, such as patient limits, that limit access to any forms of FDA-approved
medication-assisted treatment (MAT), counseling, inpatient/residential treatment, and
other treatment modalities, particularly fail-first protocols and frequent prior
authorizations. All primary care providers employed by the above-mentioned health
systems should screen for alcohol and drug use and, directly or through referral,
provide treatment within 24 to 48 hours.
Reimbursement rates for SUD treatment services are typically lower than those for other health
conditions. Private and public insurers complain that they cannot find enough quality providers
for their networks. The provision of SUD treatment, often in the form of counseling and
psychosocial services, has a different business and service model than other health conditions.
Lack of sufficient reimbursement impedes the ability of professionals and practices to implement
high-quality and consistent care, including but not limited to the use of EHRs, the
implementation of evidence-based practices, and the routine use of quality metrics. Moreover,
the disincentives are so significant that many practitioners no longer take insurance, diminishing
access to care even when there appears to be sufficient capacity. Such differential reimbursement
strategies exist in the hospital setting as well. Hospital chemical dependency units, for instance,
are paid lower rates than inpatient psychiatric facilities.
34. The Commission recommends HHS review and modify rate-setting (including policies
that indirectly impact reimbursement) to better cover the true costs of providing SUD
treatment, including inpatient psychiatric facility rates and outpatient provider rates.
Enforcing the Mental Health Parity and Addiction Equity Act (MHPAEA)
Spearheaded by Commission member former Congressman Kennedy, MHPAEA aimed to build
upon the patient protections enacted by the Mental Health Parity Act (MHPA) passed in 1996,
which provided that large group health plans could not impose annual or lifetime dollar limits on
mental health benefits that are less favorable than any such limits imposed on medical/surgical
benefits. In other words, parity is a simple concept that requires health insurance plans to offer
behavioral health coverage that is comparable, and equal to, the coverage for physical health. In
reality, creating appropriate parity regulations, and enforcement of parity laws, is far from simple.
MHPAEA extended these parity requirements to SUDs, but legislation did not require large group
health plans and health insurance carriers to cover mental health or SUD benefits. The Affordable
Care Act changed this by requiring coverage of mental health and SUD services as an essential
health benefit in individual and small group plans.
However, while parity is a legal requirement, the existing means of monitoring and enforcing the
parity act are insufficient. The sole means of enforcement under the parity act is equitable relief
against the buyer of the insurance plan; and for the employer-based plans that are self-funding,
DOL is presently permitted to enforce MHPAEA against only the employer, rather than the
insurance company administering the benefits. The Commission heard from numerous
organizations, such as the Parity Implementation Coalition, the Partnership for Drug-Free Kids,
the National Council for Behavioral Health, Shatterproof, ASAM, and the American Academy of
Addiction Psychiatry, about the need to systematically monitor and enforce MHPAEA to ensure
parity in the coverage of mental health and addiction services.
MHPAEA has been the impetus for much progress towards parity for behavioral health coverage;
plans and employers have, by and large, done away with policies that are clear violations;
provisions such as dollar-limits, visit limits, and outright prohibitions on certain treatment
modalities that exist only on behavioral health benefits. However, what remains are violations that
are murkier and harder for regulators to discern, for example, non-quantitative treatment limits
(NQTLs). These hurdles include medical necessity reviews that are more stringent on the
behavioral health side than the medical/surgical side, limited provider networks, and onerous
prior-authorization requirements. In reality, it is often difficult to discern when a behavioral health
benefit is on par with a medical/surgical benefit as different care settings and diagnoses have
different policies regarding benefits, providers, and authorizations.
One goal of MHPAEA and other parity laws was to address cost-shifting from the commercial
sector to the public sector for the financing of substance use and mental health treatment.
Expanding the private sector share of expenditures could increase access to treatment for opioid
and other drug use disorders. As of 2014, private cost-sharing did not increase in proportion to the
private sector share of the insurance market. It financed only 18% of SUD treatment in 2014.
Legislative changes providing DOL with the ability to impose a civil monetary penalty, such as
those provided for violations of the Genetic Information Nondiscrimination Act (GINA), would
encourage private insurance companies, and employers, to satisfy their legal obligations under
MHPAEA and in turn, ensure they are adequately doing their part to address the country's opioid
epidemic.
HHS has built an online portal to help individuals who have trouble accessing behavioral health
services, including addiction treatment. This portal, available at https://www.hhs.gov/mental-
health-and-addiction-insurance-help/index.html, directs individuals to different sites, including
DOL, depending on the type of insurance coverage. The Commission applauds this project as well
as the other activities of the Federal Mental Health and Substance Use Disorder Task Force in
working towards public education and full parity compliance.
Building upon the recommendations provided in the interim report, the Commission believes the
following actions will help to ensure parity violations do not impede access to substance use
treatment.
35. Because the Department of Labor (DOL) regulates health care coverage by many large
employers, the Commission recommends that Congress provide DOL increased
authority to levy monetary penalties on insurers and funders, and permit DOL to
launch investigations of health insurers independently for parity violations.
36. The Commission recommends that federal and state regulators should use a
standardized tool that requires health plans to document and disclose their compliance
strategies for non-quantitative treatment limitations (NQTL) parity. NQTLs include
stringent prior authorization and medical necessity requirements. HHS, in consultation
with DOL and Treasury, should review clinical guidelines and standards to support
NQTL parity requirements. Private sector insurers, including employers, should review
rate-setting strategies and revise rates when necessary to increase their network of
addiction treatment professionals.
37. The Commission recommends the National Institute on Corrections (NIC), the Bureau
of Justice Assistance (BJA), the Substance Abuse and Mental Health Services
Administration (SAMHSA), and other national, state, local, and tribal stakeholders use
medication-assisted treatment (MAT) with pre-trial detainees and continuing treatment
upon release.
38. The Commission recommends DOJ broadly establish federal drug courts within the
federal district court system in all 93 federal judicial districts. States, local units of
government, and Indian tribal governments should apply for drug court grants
established by 34 U.S.C. 10611. Individuals with an SUD who violate probation terms
with substance use should be diverted into drug court, rather than prison.
39. The Commission recommends the Federal Government partner with appropriate
hospital and recovery organizations to expand the use of recovery coaches, especially in
hard-hit areas. Insurance companies, federal health systems, and state payers should
expand programs for hospital and primary case-based SUD treatment and referral
services. Recovery coach programs have been extraordinarily effective in states that
have them to help direct patients in crisis to appropriate treatment. Addiction and
recovery specialists can also work with patients through technology and telemedicine, to
expand their reach to underserved areas.
Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist
physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty
workforce is limited. About 8 years ago, an estimate was made of the need for 6,000 addiction
specialists, but that number is now insufficient given the growth of the opioid epidemic.
Addiction medicine was only formally recognized as a medical subspecialty in 2016. Currently,
46 of the Nations 160 accredited medical schools offer addiction medicine fellowships. The
first-ever addiction medicine board exam was held in September 2017. By 2021, fellowships will
be the only pathway for physicians to take the addiction medicine certification exam. Without an
adequate number of fellowships producing at least two new fellows per year, the field will
quickly atrophy. Therefore, it is important to quickly ramp up the numbers of fellowships to
address the opioid crisis. The goal is to grow the fellowships to 125 over the next five years.
Significant funding is needed to start and sustain fellowship programs.
The Health Resources and Services Administration (HRSA) provides unique vehicles for
addressing the increasing trends in opioid use, overdose, and addictions across the United States.
The agency funds health centers in urban, suburban, and rural areas, trains and strengthens the
workforce, hosts the Federal Office of Rural Health Policy, and has grant programs for several
high-need and underserved communities and populations. The 21st Century Cures Act included
funding for HRSA for addiction medicine fellowships starting in 2018. Starting this year,
fellowships will be accredited by the Accreditation Council for Graduate Medical Education,
which is a significant step toward getting funding from the VA and others.
Federal agencies should also be considering where telemedicine can play a role in ensuring
access to care for those in geographically isolated regions and underserved areas.
40. The Commission recommends the Health Resources and Services Administration
(HRSA) prioritize addiction treatment knowledge across all health disciplines.
Adequate resources are needed to recruit and increase the number of addiction-trained
psychiatrists and other physicians, nurses, psychologists, social workers, physician
assistants, and community health workers and facilitate deployment in needed regions
and facilities.
41. The Commission recommends that federal agencies revise regulations and
reimbursement policies to allow for SUD treatment via telemedicine.
42. The Commission recommends further use of the National Health Service Corp to
supply needed health care workers to states and localities with higher than average
opioid use and abuse.
Response to Overdose
Expanded Access and Administration of Naloxone
Naloxone is an opioid antagonist medication that can rapidly reverse opioid overdose. It has been
available for over forty years, has an excellent safety profile, and can be easily administered by
either intravenous or subcutaneous injection or via nasal absorption. In the interim report, the
Commission recognized the importance of ensuring naloxone is made as widely available as
possible to save lives. Consequently, the Commission recommended that all law enforcement in
the United States be equipped with naloxone, model legislation be provided to states to allow
naloxone dispensing via standing orders, and Good Samaritan laws be enacted to empower the
public to seek help (Appendix 3).
The Commission assessed the availability and accessibility of naloxone across the nation. Figure
5 below shows the means at which the public can access naloxone in community pharmacies
widely differs between the states. While there is not necessarily a naloxone supply shortage,
price increases of the various forms of naloxone continue to create affordability issues,
preventing state and local governments, as well as community organizations, from stocking
naloxone at the levels necessary to rescue more people from overdose.
43. The Commission recommends the National Highway Traffic Safety Administration
(NHTSA) review its National Emergency Medical Services (EMS) Scope of Practice
Model with respect to naloxone, and disseminate best practices for states that may need
statutory or regulatory changes to allow Emergency Medical Technicians (EMT) to
administer naloxone, including higher doses to account for the rising number of
fentanyl overdoses.
45. The Commission recommends HHS develop new guidance for Emergency Medical
Treatment and Labor Act (EMTALA) compliance with regard to treating and
stabilizing SUD patients and provide resources to incentivize hospitals to hire
appropriate staff for their emergency rooms.
46. The Commission recommends that HHS implement guidelines and reimbursement
policies for Recovery Support Services, including peer-to-peer programs, jobs and life
skills training, supportive housing, and recovery housing.
47. The Commission recommends that HHS, the Substance Abuse and Mental Health
Services Administration (SAMHSA), and the Administration on Children, Youth and
Families (ACYF) should disseminate best practices for states regarding interventions
and strategies to keep families together, when it can be done safely (e.g., using a relative
for kinship care). These practices should include utilizing comprehensive family
centered approaches and should ensure families have access to drug screening,
substance use treatment, and parental support. Further, federal agencies should
research promising models for pregnant and post-partum women with SUDs and their
newborns, including screenings, treatment interventions, supportive housing, non-
pharmacologic interventions for children born with neonatal abstinence syndrome,
medication-assisted treatment (MAT) and other recovery supports.
49. The Commission recommends that ONDCP, federal partners, including DOL, large
employers, employee assistance programs, and recovery support organizations develop
best practices on SUDs and the workplace. Employers need information for addressing
employee alcohol and drug use, ensure that employees are able to seek help for SUDs
through employee assistance programs or other means, supporting health and wellness,
including SUD recovery, for employees, and hiring those in recovery.
50. The Commission recommends that ONDCP work with the DOJ, DOL, the National
Alliance for Model State Drug Laws, the National Conference of State Legislatures, and
other stakeholders to develop model state legislation/regulation for states to decouple
felony convictions and eligibility for business/occupational licenses, where appropriate.
51. The Commission recommends that ONDCP, federal agencies, the National Alliance for
Recovery Residents (NARR), the National Association of State Alcohol and Drug Abuse
Directors (NASADAD), and housing stakeholders should work collaboratively to
develop quality standards and best practices for recovery residences, including model
state and local policies. These partners should identify barriers (such as zoning
restrictions and discrimination against MAT patients) and develop strategies to address
these issues.
Research & Development
For too long addiction and pain research have been conducted and led by separate research
communities and suffered from silos and in some cases excessive pressure from industry at the
cost of patient health. The National Drug Control Strategy has never included a pain
management emphasis despite the fact that prescription opioid misuse still is responsible for
most opioid misuse in this country and providing better pain management is essential to
preventing prescription opioid misuse and diversion that starts so many people down the path to
heroin use. Several federal agencies are best suited for shepherding research initiatives and
opportunities to combat the epidemic243 and enhance treatment options, including alternative
pain management strategies, and treatment for vulnerable populations such as pregnant women,
and substance-exposed infants. Addressing the gaps with basic, applied research, and
development can conceivably expand the range of alternatives to imperfect medications currently
used to mitigate pain or treat addiction.
52. The Commission recommends federal agencies, including HHS (National Institutes of
Health, CDC, CMS, FDA, and the Substance Abuse and Mental Health Services
Administration), DOJ, the Department of Defense (DOD), the VA, and ONDCP, should
engage in a comprehensive review of existing research programs and establish goals for
pain management and addiction research (both prevention and treatment).
56. The Commission recommends that the FDA establish guidelines for post-market
surveillance related to diversion, addiction, and other adverse consequences of
controlled substances.
Conclusion
The origins of the current opioid crisis can be traced to a sequence of at least twelve converging
events and movements that catalyzed the most devastating drug epidemic in our nations history.
A five-sentence letter to a biomedical journal in 1980, followed by other low-quality articles
claiming that opioid narcotics are safe to use universally for chronic pain, bolstered advocacy by
pain patients and professional societies to treat pain with opioids. It also instigated the opioid
pharmaceutical industry to embrace and exploit the flawed claims with aggressive marketing and
educational outreach. Government agencies and accreditation organizations then designated
pain as a fifth vital sign. Without a counterbalancing force appearing in the medical community
to question the evidence or conclusions, pain assessment became a preoccupation of healthcare
practices and opioid prescribing became an accepted solution.
Prescriptions for opioids surged, now fueled by financial and performance pressures on
physicians to satisfy patients using opioids, insurers unrestrained reimbursements for opioids, an
insufficient response of federal regulators, and lack of public unawareness of the hazards of this
class of drugs. Poor medical education on pain management, on opioid prescribing, and on
screening for high risk patients undermined the ability of conscientious physicians to safely treat
pain or addiction.
A nation awash with prescription opioids became fertile ground for diversion by acquisition from
medicine cabinets, through rogue pharmacies, rogue physicians, and for opportunistic sellers of
illicit heroin, fentanyl, and other deadly opioids. The Commission has reflected on this history,
for it is a compelling source for solutions to contain this national nightmare, solutions that are
complex and multi-dimensional.
By the very nature of our federal-state-local governance, most solutions require responses at all
levels of government. Some need the cooperation and the support of private institutions, such as
commercial insurers, companies engaged in data analytics, academic institutions, or individuals
who have inadvertently contributed to this crisis. Unintentional contributors to the crisis are
recognizing earlier missteps and devising strategies to reverse engineer decisions with
prudence.
The goals of the recommendations included in this report are to promote prevention of all drug
use with effective education campaigns and restrictions in supply of illicit and misused drugs. To
achieve supply reduction, we recommend shaping prescribing practices by improved medical
education, by alternatives to pain management, as appropriate, by enhancing physician
awareness of high risk patients though substance use, mental, and medical screenings and
interrogation of PDMPs, insurance company oversight, and by interdiction of deadly opioids.
Treatment and overdose rescue are both distinct and inextricably linked efforts. Overdose rescue
procedures need to be opportunistic and include access to trained personnel, to medications, and
to treatment services. Administering naloxone to a person who has overdosed and then
abandoning them without offering medication and same-day entry to treatment is short-sighted
and inadequate.
Treatment services need to be improved, foremost by developing thoughtful national evidence-
based standards of care, record-keeping, and long-term support. In view of the need, expansion
of services is imperative and so are surmounting barriers to medications, limited healthcare
workforce, to insurance reimbursement and ensuring high-quality care and long-term recovery
support services.
The Commission strongly supports research and development of alternatives to opioids for pain
management, treatment and rescue, and of modern medical devices essential to improving our
responses. The Commission also strongly recommends real-time data analytics to inform our
mission and accomplishments. Above all, each recommendation should have accountability
built-in and be subjected to measurable goals, quantitative solutions, and measurable outcomes.
The Federal Government now must develop a level of accountability that has not been imposed
rigorously in the past.
Lessons learned. A catalog of lessons learned can guide our nation in devising current solutions
and alerting future generations on how to avoid inevitable emerging and potentially devastating
drug-related crises. Important lessons can be extracted from earlier imprudence. The current
focus on opioids is driven by the devastatingly high death rates. While death is the ultimate
catastrophe, many psychoactive drugs with abuse potential do not precipitate an overdose crisis
nor death as dramatically as do opioids. Nonetheless, other drugs can be markedly detrimental to
the brain, body, and behavior.
Low quality evidence that opioids are innocuous for chronic pain management was
accepted without scrutiny, by the healthcare system, by physicians, medical schools,
regulatory bodies, and insurers. High-quality assessment of the addictive potential of
orally bioavailable opioids should have been imposed by the FDA.
Constant vigilance is necessary to recognize if marketing efforts are suppressing
scientific evidence (e.g. addiction) and common sense. Early scientific scrutiny of
dubious claims should be a key priority of regulatory agencies and physicians.
Engage all stakeholders when creating standards and actionable outcomes. Do not restrict
input to those who passionately favor a substance. Advocates may be less willing or able
to see unintended consequences than others.
The approval process of medications with abuse liability should not be restricted to drug
safety and efficacy in short term clinical trials. The drug approval process should expand
its oversight and consider the number of doses and duration of a prescription for specific
indications, the possibility of misuse, diversion, and tampering, and other consequences
not traditionally a component of evidence required in the approval process.
Anticipate unintended consequences and devise effective data analytics, monitoring, and
responses at the outset of a trend. A small, but significant portion of patients and other
users or misusers of diverted prescription opioids transitioned to heroin. Screening for
OUD when reducing opioid supply or creating a tamper-resistance formulation, and
implementing procedures to assist treating OUD patients conceivably could have avoided
the transition for some people.
Apply the lessons learned to current movements to medicalize and legalize other
Schedule 1 drugs. The catalyst of the opioid crisis was a denial of its addictive potential.
Pharmaceutical sponsorship of medical society events needs rigorous oversight and
review.
Without adequate training in pain management and in addiction diagnosis and treatment,
the medical establishment was caught off guard and unprepared for iatrogenic opioid
addiction. Training in these disciplines should be mainstreamed into every level of
medical education, to address the current crisis and to prepare for inevitable iterations.
Healthcare insurers have a significant role in attenuating this public health crisis. They
can reduce opioid supply by declining reimbursement for unnecessary opioid
prescriptions, and facilitate recovery by seamless reimbursement for medications and
treatment services. Federal oversight on insurance company practices was inadequate as
the crisis expanded.
Current Federal Programs and Funding Landscape
Overview
Congress has not enacted full year appropriations for fiscal year (FY) 2018, which began
October 1, 2017. The Federal Government is operating under a Continuing Resolution (CR) that
will expire in December 2017. The funding levels presented in this report are consistent with the
funding levels represented in the FY 2018 Presidents Budget, including FY 2018 Request levels
and FY 2017 CR (annualized) estimates.
The Presidents FY 2018 Budget Request supports $27.8 billion for drug control efforts spanning
prevention, treatment, interdiction, international operations, and law enforcement across 14
Executive Branch departments, the Federal Judiciary, and the District of Columbia. This
represents an increase of $279.7 million (1.0%) over the annualized CR level in FY 2017 of
$27.5 billion.
Within this total, the Budget supports $1.3 billion in investments authorized by the
Comprehensive Addiction and Recovery Act (CARA), the 21st Century Cures Act, and other
opioid-specific programs to help address the opioid epidemic.
Medication-Assisted Treatment in the Criminal Justice System. The Bureau of Prisons (BOP)
budget contains $1.0 million in new resources to expand the MAT Pilot. The pilot provides an
opportunity to evaluate whether MAT should be expanded in the corrections setting.
Residential Substance Abuse Treatment. The Office of Justice Programs budget contains
$12.0 million for the Residential Substance Abuse Treatment (RSAT) program for state
prisoners, level with funding for FY 2016 and the FY 2017 CR. The program was established to
help state and local governments develop, implement, and improve residential substance abuse
treatment programs in correctional facilities, and establish and maintain community-based
aftercare services for probationers and parolees. It is intended improve public safety and reduce
criminal recidivism by helping offenders become drug-free and learn the skills needed to sustain
themselves upon return to the community.
Enhanced Drug Enforcement Efforts. The Budget provides increases to federal law
enforcement agencies aimed at reducing the flow of illicit drugs into the country and increasing
investigations of transnational criminal organizations, violent gangs, and drug traffickers.
Specifically:
The FY 2018 Budget includes funding to maintain and expand capacity to fight against heroin
and other illicit drugs at the DOJ. This includes a total of $2.6 billion for the DEA, including $21
million in new discretionary resources are requested for DEA and $32 million in new mandatory
resources for the DEAs Diversion Control Program to reduce the diversion and abuse of
pharmaceutical controlled substances and listed chemicals, including prescription opioids. The
overall DEA request for FY 2018 is an increase of $158.1 million over the FY 2016 level and
$150.3 million over the FY 2017 CR level. The FY 2018 Request for the DOJ also includes
$526.0 million for Organized Crime and Drug Enforcement Task Force (OCDETF) to support
heroin enforcement efforts, address transnational organized crime, and to reduce violent crime in
cities across the nation. The request is an increase of $14.0 million above the FY 2016 and $15.0
million more than the FY 2017 CR and will enhance heroin enforcement efforts, address
transnational organized crime, and reduce violent crime in cities across the nation.
Drug Prevention. The Drug Free Communities (DFC) Support Program is built upon the idea
that local problems require local solutions. DFC funding provides for the bolstering of
community infrastructure to support environmental prevention strategies to be planned,
implemented, and evaluated in communities across the United States, Territories and
Protectorates. The DFC Program is guided by local communities who identify and develop
evidence-based strategies to reduce drug use and its consequences. For FY 2018, $91.8 million
will fund approximately 659 DFC grants and continue the DFC National Cross-Site Evaluation.
This program received $95.0 million in FY 16 and $94.8 million in FY 2017 through CR.
Addressing Domestic and Transnational Organized Crime. The Administration will employ
tools to disrupt the flow of illicit drugs into our country, and reduce drug trafficking
domestically.
In an effort to enhance security at the Southwest Border, in the FY 2018 Presidents Budget,
CBP requests $260.5 million to fund acquisition, delivery, and sustainment of prioritized border
security capabilities. This is a new activity, reflecting the Presidents commitment to border
security.
The HIDTA program, created by Congress with the Anti-Drug Abuse Act of 1988, aids federal,
state, local, and tribal law enforcement agencies operating in areas determined to be critical drug-
trafficking regions of the United States. A total of $246.5 million is requested for the HIDTA
program in FY 2018, a decrease from the FY 2016 funding level of $250.0 million and the FY
2017 CR funding level of $249.5 million.
The Comprehensive Addiction and Recovery Act (CARA)
The Comprehensive Addiction and Recovery Act (CARA) authorized new programs to help fight
the scourge of opioid abuse plaguing our Nation, and authorized appropriations for existing
programs to continue their work. Highlights of these programs are below:
In FY 2018, SAMHSA is requesting $12.0 million for the Preventing Prescription Drug/Opioid
Overdose-Related Deaths (PDO II) program, authorized in CARA. FY 2018 is the first-time
appropriations for this newly-authorized program will be requested. The purpose of this program
is to reduce the number of prescription drug/opioid overdose-related deaths and adverse events
among individuals at risk for OUD. Applicants will train first responders and members of other
key community sectors at the state, local government, and tribal levels to implement secondary
prevention strategies, such as the administration of naloxone through FDA-approved delivery
devices to reverse the effects of opioid overdose.
SAMHSA is also requesting $1.0 million to support a new cohort of grants through the Building
Communities of Recovery program. This program mobilizes resources within and outside of the
recovery community to increase the prevalence and quality of long-term recovery support for
people with SUDs. These grants support the development, enhancement, expansion, and
delivery of recovery support services, as well as promotion of and education about recovery.
At the DOJ, the Office of Justice Programs is requesting $20.0 million for grants under the
Comprehensive Opioid Abuse Program. This new program aims to support cross-system
collaboration; develop and implement strategies to reach survivors of non-fatal overdoses and
their loved ones; provide treatment and recovery support services; expand diversion and
alternative to incarceration programs; expand services in rural or tribal communities; implement
and enhance PDMPs; and assess the impact of new strategies.
At the VA, $50 million authorized under CARA is being requested for activities to increase
opioid safety practices and improve care for Veterans within the Veterans Health Administration.
VA began implementation of these activities with CR funds in FY 2017.
Prevention
Preventing drug use before it starts is a fundamental element of a comprehensive approach to
drug control. Federal resources totaling $1.3 billion in support of education and outreach
programs has been requested to educate young people about the consequences of drug use and
prevent youth initiation. This represents a decrease of $167.5 million (11.1%) over the FY 2017
level; the major efforts are highlighted below:
Department of Health and Human Services Substance Abuse and Mental Health Services
Administration
Twenty percent of the $1.9 billion (i.e., $370.9 million) Substance Abuse Prevention and
Treatment Block Grant is the minimum set aside to support prevention services. State Substance
Abuse Administering Agencies use these funds to develop infrastructure and capacity specific to
SUD prevention. Some State Substance Abuse Administering Agencies rely heavily on the 20%
set-aside to fund prevention, target gaps in prevention services, and enhance existing program
efforts.
Educations Prevention Efforts ($48.9 million)
Department of Education
The $48.9 million request includes $46.3 million for School Climate Transformation Grants and
related technical assistance. These funds help create positive school climates through multi-tiered
decision-making frameworks that guide the selection, integration, and implementation of the best
evidence-based behavioral practices. A key aspect of this multi-tiered approach is that it
provides differing levels of support and interventions to students based on their needs. In
schools where these frameworks are implemented well, there is evidence that youth risk factors
are improved; improved risk factors are correlated with reduced drug use, among other improved
behaviors.
Substance Use Disorders Treatment for Military Service Members/Families ($76.7 million)
Department of Defense Defense Health Program
DODs Defense Health Program provides medical and dental services, including treatment for
SUDs, for all members of the armed forces to include all eligible beneficiaries, including military
family members. In addition to treatment services, the Defense Health Program also conducts
alcohol and SUD research.
Interdiction
The United States continues to face a serious challenge from the large-scale smuggling of drugs
from abroad that are distributed to every region of the Nation. In FY 2018, the Administrations
request includes $5.0 billion to support the efforts of federal law enforcement agencies, the
military, the intelligence community, and our international allies to support collaboration to
interdict or disrupt shipments of illegal drugs, their precursors, and their illicit proceeds. The FY
2018 request represents an increase of $453.4 million, (9.9%) above the FY 2017 annualized CR
level. The major efforts are highlighted below.
DODs counterdrug programs detect, monitor, and support the disruption of drug trafficking
organizations. Additionally, DOD coordinates interagency resources and force requirements of
air and surface assets in the Western Hemisphere Transit Zone.
International Efforts
Illicit drug production and trafficking generate huge profits and are responsible for the
establishment of criminal enterprise networks that are powerful and corrosive forces that destroy
the lives of individuals, tear at the social fabric, and weaken the rule of law in affected countries.
In FY 2018, $1.4 billion is requested for international drug control efforts, a decrease of
$146.1 million (9.6%) below the FY 2017 annualized CR level. These funds are requested to
support the efforts of the United States Government and our international partners around the
globe to meet the challenges of illicit trafficking of all drugs, including synthetics and precursors,
and illicit substance use. The major efforts in this area include the following.
The international support programs of DODs Combatant Commands detect, interdict, disrupt, or
monitor activities related to drug trafficking organizations and transnational criminal
organizations. In the Western Hemisphere Transit Zone, DOD functions as the command and
control support for counterdrug activities for federal, state, local and international partners.
Table 3. Federal Drug Control Spending by Function, FY 2016 FY 2018 (Budget Authority in Millions)
FY 2016 FY 2017 FY 2018 FY17 - FY18 Change
Final CR Request Dollars Percent
Function
Treatment $9,845.1 $10,580.8 $10,783.4 $202.6 1.9%
Percent 36.6% 38.5% 38.9%
Supply/Demand
Demand Reduction $11,331.5 $12,088.2 $12,123.3 $35.1 0.3%
Percent 42.2% 44.0% 43.7%
Court Services and Offender Supervision Agency for the District of 55.4 55.3 56.1
Columbia
Department of Defense
1
Drug Interdiction and Counterdrug Activities (incl. OPTEMPO, 1,302.8 1,299.4 1,127.8
DSCA, and OCO)
Defense Health Program 76.7 75.8 76.7
Total DoD 1,379.5 1,375.1 1,204.6
Department of Education
Office of Elementary and Secondary Education 50.3 49.1 48.9
Department of Labor
Employment and Training Administration 5.7 6.0 6.0
5
Department of State
Bureau of International Narcotics and Law Enforcement Affairs 405.3 404.5 290.3
United States Agency for International Development 70.5 70.4 83.6
Total State 475.8 474.9 373.9
Department of Transportation
Federal Aviation Administration 30.4 31.6 31.7
National Highway Traffic Safety Administration 3.5 2.7 2.7
Total Transportation 33.8 34.3 34.4
1.
Due to statutory changes included in the FY 2017 National Defense Authorization Act that consolidated the
DODs security sector assistance authorities, funding for building foreign partner counter -drug enforcement
capacities is now included in DOD's Defense Security Cooperation Agency's budget request.
2.
The estimates for the CMS reflect Medicaid and Medicare benefit outlays (excluding spending under Medicare
Part D) for substance use disorder treatment; they do not reflect budget authority. The methodology for Medicaid
estimates has been refined from prior years to more accurately reflect spending. The estimates were developed
by the CMS Office of the Actuary.
3.
Includes budget authority and funding through evaluation set-aside authorized by Section 241 of the Public
Health Service (PHS) Act.
4.
Funding for the FY 2018 column excludes a proposed rescission of unobligated balances.
5.
Funding for 2017 column is a mechanical calculation that does not reflect decisions on funding priorities.
6.
Detail may not add due to rounding
Charter, Presidents Commission on Combating Drug
Addiction and the Opioid Crisis
Appendices
Appendix 1. Acronyms
ACA: Affordable Care Act
ADAM: Arrestee Drug Abuse Monitoring Program
AED: Advanced Electronic Data
AUD: alcohol use disorder
AHRQ: Agency for Healthcare Research and Quality
ASAM: American Society of Addiction Medicine
BJA: Bureau of Justice Assistance
BOP: Bureau of Prisons
CARA: Comprehensive Addiction and Recovery Act
CBP: U.S. Customs and Border Protection
CDC: Centers for Disease Control and Prevention
CHW: community health worker
CME: continuing medical education
CMS: Centers for Medicare and Medicaid Services
CRP: collegiate recovery programs
DAWN: Drug Abuse Warning Network
DEA: Drug Enforcement Administration
DHS: Department of Homeland Security
DOD: Department of Defense
DOE: Department of Education
DOJ: Department of Justice
DOL: Department of Labor
DOT: Department of Transportation
DTO: Drug Trafficking Organization
ED: Emergency Department
EHR: electronic health records
EMR: emergency medical responder
EMS: emergency medical services
EMT: emergency medical technician
EMTALA: Emergency Medical Treatment and Labor Act
EPCS: electronic prescribing of controlled substances
ER: extended-release
FAA: Federal Aviation Administration
FDA: U.S. Food and Drug Administration
FLETC: Federal Law Enforcement Training Center
HCAHPS: Hospital Consumer Assessment of Healthcare Providers and Systems
HCPCS: Healthcare Common Procedure Coding System
HCV: hepatitis C virus
HHS: U.S. Department of Health and Human Services
HIDTA: High Intensity Drug Trafficking Areas
HIV: human immunodeficiency virus
HRSA: Health Resources and Services Administration
HUD: heroin use disorder
IMD: Institutes of Mental Disease
IMF: USPS International Mail Facilities
INL: Bureau of International Narcotics and Law Enforcement Affairs
IR: immediate-release
MAT: Medication-Assisted Treatment
MDI: medicolegal death investigation
ME/C: medical examiners and coroners
MHPAEA: Mental Health Parity and Addiction Equity Act
NARR: National Alliance for Recovery Residents
NASEM: National Academies of Sciences, Engineering, and Medicine
NAS: neonatal abstinence syndrome
NHTSA: National Highway Traffic Safety Administration
NIAAA: National Institute on Alcohol Abuse and Alcoholism
NIC: National Institute on Corrections
NIDA: National Institute on Drug Abuse
NIH: National Institutes of Health
NQTL: non-quantitative treatment limits
NSC: National Security Council
NSDUH: National Survey on Drug Use and Health
NPS: new psychoactive substances
ONDCP: Office of National Drug Control Policy
OTP: opioid treatment programs
OUD: opioid use disorder
PDMP: prescription drug monitoring program
RCO: recovery community organization
RSS: recovery support services
SAMHSA: Substance Abuse and Mental Health Services Administration
SBIRT: Screening, Brief Intervention, and Referral to Treatment
SUD: substance use disorder
USAID: United States Agency for International Development
USCG: United States Coast Guard
USPS: United States Postal Service
USPIS: United States Postal Inspection Service
USPSTF: United States Preventative Services Task Force
VA: Department of Veteran Affairs
VBP: Value-Based Purchasing
Appendix 2. History of Opiate Use and Abuse
The opium poppy was a medicinal plant used by ancient civilizations. It blunted pain; elevated
mood; relaxed; dulled stress, melancholy, and anxiety; and induced sleep. With the dawning of
modern chemistry in the early 1800s, morphine, codeine, and thebaine were purified from the
opium poppy Papaver somniferum, and their chemical structures identified. Scientific curiosity
or optimization of medicinal properties drove chemists to synthesize variations of these naturally
occurring opioids. The end products included heroin, oxycodone, oxymorphone, hydrocodone,
hydromorphone, and others.
To avoid reliance on the poppy plant for opioids, de novo compounds such as methadone,
meperidine, fentanyl, tramadol, U47700, were subsequently created. These drugs were
structurally distinct from morphine yet targeted the same pain-reducing/pleasure-inducing
receptors/circuits as plant-derived morphine analogs to engender pain relief, suppression of
cough and intestinal function and chemical coping of psychological distress. Susceptible
individuals, whether medical or non-medical users discovered the euphoriant properties of potent
opioids delivered rapidly into the brain, especially by smoking or injection.
Opioid mechanisms. Opioid analgesics target opioid signaling systems within circuits engaged
in diverse homeostatic mechanisms, especially management of pain, anxiety, stress, intestinal
motility, cough mechanisms and hedonic pleasure. Opioid signaling is comprised of endogenous
chemical neurotransmitters (small and large mobile peptides such as endorphins that transmit
signals) and their corresponding opioid receptors (large anchored proteins that interpret signals).
These signaling systems are widely distributed throughout the human brain and body. Three
major opioid receptors ( or mu, or kappa, and or delta), their subtypes and splice variants
have been identified. Opioids activate one or more of these G-proteincoupled transmembrane
molecules, to trigger diverse responses governed by splice variants, post-translational
modifications, and receptor heterodimer or homodimer formation.254 All exogenous opioids that
target the -opioid receptor suppress pain perception, slow gastrointestinal motility, attenuate
cough, and induce pleasurable sensations or intense euphoria. At sufficiently high doses,
activation of -opioid receptors in the brain stem can depress respiration, leading to reduced
blood flow and oxygen in the brain and even death. Frequent exposure to opioids leads to
tolerance, a diminution of specific signaling functions of the mu opioid receptor (e.g., euphoria
and respiratory depression), which may drive the user to escalate drug doses to levels that can be
fatal in the drug-nave or in abstinent former users. If high dose opioids are reintroduced during
abstinence (e.g. released prisoners or in long term recovery), the risk of a lethal overdose is grave
as tolerance to opioids wanes during abstinence.
Historical Origins of Iatrogenic Opioid Addiction. In the mid- to late-19th century, opioid use
rose dramatically, fueled by physicians unrestrained opioid prescriptions (morphine, laudanum,
paregoric, codeine, heroin) for pain or other ailments, by inclusion of opioids in aggressively
promoted patent medicines, and by liberal use of opioid-based treatments for injuries and
diseases gnawing at Civil War combatants and veterans. Opioids were undoubtedly more
effective and reliable medications for a variety of ailments, compared with existing alternatives.
During this first wave, physicians were largely responsible for iatrogenic addiction to opioids
among patients. By 1900, 1 in 200 people were addicted in the United States. In parallel with
clinicians and pharmacists issuing unrestrained opioid supplies to treat medical ailments and
addiction, profiteers organized clandestine, illicit opioid distribution networks. Powered by
unregulated international production and shipments of opium, opium dens proliferated in the
United States and created a non-medical, addicted population among denizens of these
sites.255,256,257 The steep rise in consumption of medical opioids or smoked opium led to an
alarming surge of addictions, either medically-induced, or resulting from opium smoking. The
two populations did not cross-over, nor merge regarding drug sources, types of opioids, or
routes of administration. This nation-wide crisis extended across socio-economic strata, and
reached urban and rural areas. Thereafter, smaller scale waves of heroin addiction surfaced
periodically during the 20th century, but these were confined to large cities.
Response to the First Crisis. Medical professionals, federal, local, and international regulatory
bodies awakened to the epidemic of iatrogenic and situationally-based opioid addiction. One
physician James F.A. Adams wrote compellingly on the adverse side effects of these medicinal
drugs - depression, constipation, and the opium habit, (addiction). Eventually, the first
epidemic of opioid addiction was contained and then reversed by physicians, pharmacists,
medical education, voluntary restraint, combined with federal regulations and law enforcement.
In 1890, the U.S. government began taxing opium and by 1906, the Pure Food and Drug Act was
passed, which required manufacturers to disclose the contents of their medicinal products to
consumers. Three years later Congress passed the Opium Exclusion Act, banning its import for
opium smoking. The International Opium Convention in the Hague and the Harrison Act of 1914
taxed and regulated the sale and distribution of opium and cocaine-based products, the first
broadly based prohibition in American history. Opioids remained available for short-term
medical use, but not for maintenance of addiction. Doctors and pharmacists who violated the
Act, which discouraged morphine use to sustain addiction, were arrested. The United Nations
Single Convention on Narcotic Drugs in 1961 and the Controlled Substances Act (CSA) of 1970
(Title II of the Comprehensive Drug Abuse Prevention and Control Act) established federal U.S.
drug policy on regulating the manufacture, importation, possession, use and distribution of
certain substances. The CSA was the national legislation for implementing the Single
Convention on Narcotic Drugs. The DEA, the enforcement branch of the CSA, was charged with
registration of physicians, stringent annual production quotas, chain-of-custody and other
regulatory oversight.
Appendix 3. Interim Report, Presidents Commission on Combating
Drug Addiction and the Opioid Crisis
Dear Mr. President:
I am proud to present to you today the interim report prepared by your Commission on
Combating Drug Addiction and the Opioid Crisis. This interim report is just a start; our work is
ongoing and we will have more to share with you and the nation later in the Fall of 2017. We
now recommend several actions for you to take as our nations Chief Executive and someone
who spoke passionately on this issue in the 2016 campaign.
Our nation is in a crisis. Your Executive Order recognized that fact. The work of your
Commission so far acknowledges the severity of this national problem.
According to the Centers for Disease Control (CDC), the most recent data estimates that 142
Americans die every day from a drug overdose. Our citizens are dying. We must act boldly to
stop it. The opioid epidemic we are facing is unparalleled. The average American would likely be
shocked to know that drug overdoses now kill more people than gun homicides and car crashes
combined. In fact, between 1999 and 2015, more than 560,000 people in this country died due
to drug overdoses this is a death toll larger than the entire population of Atlanta. As we have
all seen, opioids are a prime contributor to our addiction and overdose crisis. In 2015, nearly
two-thirds of drug overdoses were linked to opioids like Percocet, OxyContin, heroin, and
fentanyl. This is an epidemic that all Americans face because here is the grim reality: Americans
consume more opioids than any other country in the world. In fact, in 2015, the amount of
opioids prescribed in the U.S. was enough for every American to be medicated around the clock
for three weeks.
Since 1999, the number of opioid overdoses in America have quadrupled according to the CDC.
Not coincidentally, in that same period, the amount of prescription opioids in America have
quadrupled as well. This massive increase in prescribing has occurred despite the fact that there
has not been an overall change in the amount of pain Americans have reported in that time
period. We have an enormous problem that is often not beginning on street corners; it is
starting in doctors offices and hospitals in every state in our nation.
But, the challenge of reducing opioid supplies has evolved. As access to prescription opioids
tightens, consumers increasingly are turning to dangerous street opioids, heroin, fentanyl alone
or combined, and mingled with cocaine or other drugs. In 2016, specific states witnessed an
escalating number of overdose deaths due to heroin and/or fentanyl(s), in some states vastly
exceeding deaths due to prescription opioids.
In 2015, 27 million people reported current use of illegal drugs or abuse of prescription drugs.
Despite this self-reporting, only 10 percent of the nearly 21 million citizens with a substance use
disorder (SUD) receive any type of specialty treatment according to the most recent National
Survey on Drug Use and Health. This is contributing greatly to the increase of deaths from
overdose.
Over forty percent of people with a substance use disorder also have a mental health problem,
but less than half of these people receive treatment for either issue. The reasons for these
treatment gaps are many, including lack of access to care, fear of shame and discrimination,
and lack of motivation to seek treatment.
This Commission has been hard at work to meet the goals set for us in the Executive Order on
March 29th, 2017. As a Commission, we have already met with leading national organizations in
the addiction space, and we have received information and recommendations from countless
individuals and groups, all of whom share in our commitment to beating this epidemic. The
Commission thanks all the individuals and organizations, including Governors and
representatives from Governors Offices from around the country, that have reached out to
offer their experiences, expertise, and input.
In addition to conducting phone calls with Governors and their teams in all 50 states, we also
held a listening session with bi-partisan members of Congress, and key cabinet members of
your Administration. Individual Commission members have organized listening sessions and
solicited recommendations from treatment providers, addiction psychiatrists and other
physicians, data analysts, professional medical and treatment societies, medical educators,
healthcare organizations, pharmacoepidemiologists, and insurance providers. Outreach also
has been made to scientists with broad expertise in pain, addiction biology and treatment.
The first public meeting of the Commission was held on June 16th at the White House, and was
a great success. The Commission members heard comprehensive public testimony by nine
leading nonprofits, and have received more than 8,000 comments from the public, including
comments from at least 50 organizations.
This information was reviewed by the Commission members and helped inform this interim
report.
The first and most urgent recommendation of this Commission is direct and completely within
your control. Declare a national emergency under either the Public Health Service Act or the
Stafford Act. With approximately 142 Americans dying every day, America is enduring a death
toll equal to September 11th every three weeks. After September 11th, our President and our
nation banded together to use every tool at our disposal to prevent any further American
deaths. Your declaration would empower your cabinet to take bold steps and would force
Congress to focus on funding and empowering the Executive Branch even further to deal with
this loss of life. It would also awaken every American to this simple fact: if this scourge has not
found you or your family yet, without bold action by everyone, it soon will. You, Mr. President,
are the only person who can bring this type of intensity to the emergency and we believe you
have the will to do so and to do so immediately.
The Commission has been urged by every Governor, numerous treatment providers,
parents, and non-profit advocacy organizations to eliminate the IMD exclusion within the
Medicaid program. This component of the Social Security Act prohibits federal Medicaid
funds from reimbursing services provided in an inpatient facility treating mental diseases
(including SUDs) that have more than 16 beds. This exclusion makes states entirely
responsible for Medicaid-eligible patients in inpatient treatment facilities, including patients
undergoing withdrawal management in addiction treatment facilities rather than hospitals.
The Commission members that serve as Governors, as well as individuals and organizations
that treat Medicaid patients, are intimately aware of how the IMD exclusion impacts the
ability to serve patients with severe SUDs that are best served in an inpatient setting. The
Commission recognizes that legislation would be necessary to repeal the exclusion in its
entirety. However, certainly after an emergency declaration by the President (and arguably
even without it) the Department of Health and Human Services (HHS) Secretary would be
empowered to immediately grant waivers to each state that requests one. This is the single
fastest way to increase treatment availability across the nation.
Mandate prescriber education initiatives with the assistance of medical and dental
schools across the country to enhance prevention efforts. Mandate medical education
training in opioid prescribing and risks of developing an SUD by amending the Controlled
Substance Act to require all Drug Enforcement Agency (DEA) registrants to take a course
in proper treatment of pain. HHS should work with partners to ensure additional training
opportunities, including continuing education courses for professionals.
The FDA should also work with the ACCME to develop data analytics to determine whether
courses change practices, increase patient referrals to treatment, and methods to improve
compliance consistent with opioid prescribing education.
Clinicians need more detailed and specific guidance on drug choice, dose, and quantity to
be dispensed in treating specific pain conditions. We also recommend a detailed analysis of,
and solutions to clinical problems encountered in applying recommended guidelines.
MAT has proven to reduce overdose deaths, retain persons in treatment, decrease use of
heroin, reduce relapse, and prevent spread of infectious disease. Expansion of MAT
availability for qualified individuals and for short- or long-term treatment is an essential
component of treatment services. Yet approximately 10 percent of conventional drug
treatment facilities in the United States provide MAT for opioid use disorder.
Individuals seeking SUD treatment, and even those currently enrolled in a treatment
system, often find barriers to using MAT as a component of their treatment. Particularly for
populations with opioid use disorders (OUDs) involved in the criminal justice system, there
is often inadequate access to FDA-approved medications that are proven to improve
outcomes as part of a full continuum of care. Multiple studies have shown that individuals
receiving MAT during and after incarceration have lower mortality risk, remain in treatment
longer, have fewer positive drug screens, and have lower rates of recidivism than other
individuals with OUDs that do not receive MAT. The DOJ, in consultation with HHS and
ONDCP, should be directed to increase the use of MAT for OUDs in these correctional
settings.
In addition, the Centers for Medicare & Medicaid Services (CMS) should require all
federally-qualified health centers (FQHCs) to mandate that their staff physicians, physician
assistants, and nurse practitioners possess waivers to prescribe buprenorphine.
There are several barriers to the use of MAT, including a prevalent belief that use of MAT
does not constitute true recovery or sobriety. The Federal Government, as a major
purchaser of health care services, has a tremendous opportunity to increase the availability
of MAT for individuals with OUDs. For example, across the Veterans Administration (VA)
and Indian Health Services, there is a lack of providers able to prescribe/administer MAT.
For Medicare patients, the Part B physician benefit does not cover methadone treatment
and the Part D pharmaceutical benefit does not cover it either, as it is administered by a
medical professional. CMS should send a state health official letter requesting that state
Medicaid programs cover all FDA-approved MAT drugs for OUD.
Additionally, all FDA-approved MAT should be offered by authorized providers, not just one
or two of these approved options. These decisions of which (if any) MAT to be used must
be based upon what is best for the patient, not what is best for the provider. This can be
mandated by the Executive Branch.
Finally, we urge you to instruct the NIH to begin to immediately work with the
pharmaceutical industry in two areas; the development of additional MAT options and the
development of new, non-opioid pain relievers based on research to clarify the biology of
pain. The nation needs more options to treat those already addicted and can help to
prevent addiction in the first place by avoiding the prescription of opioids. The NIH is best
positioned, in our opinion, to lead this effort with industry partners.
Provide model legislation for states to allow naloxone dispensing via standing orders, as
well as requiring the prescribing of naloxone with high-risk opioid prescriptions; we must
equip all law enforcement in the United States with naloxone to save lives.
Naloxone is a lifesaver that rapidly reverses opioid overdose. It is the first line of defense in
many parts of our country; if we lose someone to overdose we obviously have no chance to
treat them and return them to a productive life. We urge you to mandate, with federal
assistance, that naloxone be in the hands of every law enforcement officer in the United
States. By declaring a national emergency, you can empower the HHS Secretary to
negotiate reduced pricing for all governmental units. Forty-seven states have expanded
access to naloxone in some form. The Federal Government should ensure that naloxone is
made available when there is the greatest chance for an overdose. Accordingly, model
legislation should include a requirement that naloxone is prescribed in combination with
any CDC-defined high-risk opioid being prescribed.
An impediment to naloxone usage and people seeking help in the event of an overdose is
the perceived threat of law enforcement involvement. Overly restrictive or punitive laws
may prevent the uptake of naloxone or the seeking of aid in an emergency. In response,
most state legislatures and some law enforcement agencies have created a variety of
immunity and Good Samaritan laws to ensure bystanders and those experiencing an
overdose are not deterred from seeking immediate help. States vary widely in the content
of Good Samaritan laws, but they generally offer protection to people assisting at the
scene of an overdose, or seeking care for their own or anothers overdose, from civil or
criminal prosecution. As of July 2017, 40 states and the District of Columbia have enacted
some form of a Good Samaritan or 911 drug immunity law. In addition to enacting
legislation, it is crucial that states ensure the public fully understands the protections
provided by the Good Samaritan law and how it empowers them to call 911 in the case of
an overdose.
HHS and other federal agencies should be directed by you or your cabinet to make
recommendations on ways to identify persons who have overdosed and been revived with
naloxone and the feasibility of notification of their primary care and other physicians caring
for them. These primary care providers may be prescribing medications that increase future
risks of another overdose.
Prioritize funding and manpower to the Department of Homeland Securitys (DHS)
Customs and Border Protection, the DOJ Federal Bureau of Investigation (FBI), and the
DEA to quickly develop fentanyl detection sensors and disseminate them to federal, state,
local, and tribal law enforcement agencies. Support federal legislation to staunch the flow
of deadly synthetic opioids through the U.S. Postal Service (USPS).
Illicit fentanyl and fentanyl analogs are the next grave challenge on the opioid front and the
awful news is that it is much, much more deadly than hydrocodone, oxycodone or even
heroin. Since 2012, the nation has seen an alarming increase in the number of drug
overdose deaths that involve fentanyl, a synthetic opioid many times more powerful than
heroin, as well as heroin and cocaine laced with non-pharmaceutical fentanyl. Fentanyl
defies detection at our borders, as the small quantities involved for psychoactivity of
fentanyl and fentanyl analogs challenge Customs and Border Protection, USPS, and express
consignment carriers ability to detect and interdict. We are miserably losing this fight to
prevent fentanyl from entering our country and killing our citizens. We are losing this fight
predominately through China. This must become a top tier diplomatic issue with the
Chinese; American lives are at stake and it threatens our national security. Our inability to
reliably detect fentanyl at our land borders and at our international mail handling facilities
creates untenable vulnerabilities. Key federal agencies, including the DEA, DHS, FBI, and
DOJ, should coordinate pursuant to the Controlled Substances Act to intercept fentanyl
(and other synthetic opioids) in envelopes and packages at mail processing distribution
centers, and increase detection efforts using enhanced technology, more manpower, and
expanded canine deployment. Only a presidential directive will give this issue the top level
attention it deserves from DOJ, DHS, and USPS.
Provide federal funding and technical support to states to enhance interstate data sharing
among state-based prescription drug monitoring programs (PDMPs) to better track
patient-specific prescription data and support regional law enforcement in cases of
controlled substance diversion. Ensure federal health care systems, including Veterans
Hospitals, participate in state-based data sharing.
PDMPs are state-run electronic databases used to track the prescribing and dispensing of
controlled prescription drugs. They are designed to give providers access to critical
information regarding a patients controlled substance prescription history, and can help
health professionals identify patients who may be or are at risk of misusing prescription
opioids or other prescription drugs. PDMPs are also used by professional licensing boards to
identify clinicians with patterns of inappropriate prescribing and dispensing, and to assist
law enforcement in cases of controlled substance diversion. Multiple published best
practices for utilizing PDMPs, including guidelines from the Heller School for Social Policy
and Management at Brandeis University, have identified interstate data sharing among
PDMPs as a top priority to ensure that healthcare professionals and law enforcement have a
complete picture of prescribing practices and controlled substances diversion. Numerous
professional health organizations, including the American Medical Association (AMA) and
the Association of State and Territorial Health Officials (ASTHO), agree that PDMPs are an
effective and important clinical tool to combat the addiction crisis; however, they are being
significantly underutilized in the vast majority of our states. Forty-nine states now have
PDMPs but not nearly a majority of those are sharing their information. This is
unacceptable. We urge you to direct the VA and HHS to lead an effort to have all state and
federal PDMP systems to share information and to set a deadline of July 1, 2018 to achieve
this data sharing.
In addition to sharing data between states and the Federal Government, the PDMP needs to
be improved with regard to its ease of use, and inclusion of other data to assist prescribing
doctors. Ideally, clinicians should check their state PDMP before making the decision to
prescribe either an opioid or benzodiazepine (several states already have this requirement
in place), determine whether their patient has had an overdose, and other relevant
information that can be summarized into categories of high to low risk.
Better align, through regulation, patient privacy laws specific to addiction with the Health
Insurance Portability and Accountability Act (HIPAA) to ensure that information about
SUDs be made available to medical professionals treating and prescribing medication to a
patient. This could be done through the bipartisan Overdose Prevention and Patient
Safety Act/Jessies Law.
Providers and other advocates have found that certain privacy regulations, while well-
intentioned patient protections, act as a barrier to communication between providers, can
make it difficult for family members to be involved in a loved ones treatment, and limits
the ability to use electronic health records to their full potential. 42 CFR Part 2, which
requires addiction treatment professionals to acquire written patient consent before
sharing any information with a patients other health care providers, including when the
addiction treatment facility is part of a larger health care system, is a particular hindrance to
comprehensive health care. Making it administratively difficult for providers to share
information has ill-effects on patients in both physical and behavioral health settings, by
restraining physicians ability to make informed healthcare decisions.
We urge you to direct that regulation be changed to permit the sharing of this type of
information among health care providers and the loved ones of those suffering from
SUDs. Otherwise, drugs with high abuse liability may be prescribed to people with
OUD. That will lead to even more unnecessary and preventable deaths.
Enforce the Mental Health Parity and Addiction Equity Act (MHPAEA) with a standardized
parity compliance tool to ensure health plans cannot impose less favorable benefits for
mental health and substance use diagnoses verses physical health diagnoses.
As Congressman Kennedy spoke eloquently about at the first Commission meeting, there
has long been a difference in how individuals with health insurance receive treatment and
medication for physical health diagnoses versus mental health and SUD diagnoses. The
Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) prohibits health insurance
plans that cover behavioral health from imposing benefit limitations on mental health or
SUD treatment that are less favorable than limitations imposed on medical or surgical
benefits. Benefit limitations can be quantitative, such as visit limits, or non-quantitative,
such as pre-authorization requirements. But not providing real parity is already illegal. The
Commission urges you to direct the Secretary of Labor to enforce this law aggressively and
to penalize the violators.
The Commission heard from numerous organizations, including ASAM and the American
Academy of Addiction Psychiatry, about the need to systematically monitor and enforce
MHPAEA with a standardized tool, and actual penalties for non-compliance, to ensure parity
in the coverage of mental health and addiction treatment services. The Labor Secretary,
with appropriate direction from you, is the person to do this.
At this point, the largest outstanding issue is treatment limits. Patients seeking addiction
treatment, including MAT, are often subjected to dangerous fail-first protocols, a limited
provider network, frequent prior authorization requirements, and claim denials without a
transparent process. The Commission applauds SAMHSAs work with multidisciplinary
teams from states to improve parity enforcement and public education. However, we need
robust enforcement of the parity law by the state and federal agencies responsible for
implementing the law. Regulators should be required to levy penalties against health plans
that violate MHPAEA, and information about parity violations should be made available to
the public.
It is not only critical that the Federal Government provide sufficient resources to prevent and
combat this disease; it must also provide the easiest pathway for private providers and local
and state governments to achieve success.
That is why the Commission, as a primary focus of the final report, is undertaking a full-scale
review of federal programs, regulations, laws, and funding mechanisms targeted toward
addressing addiction.
In addition to a full review of federal funding and programs and obstacles and opportunities for
treatment, the final report will include, but not be limited to, a more thorough examination of
the following issues:
Development of a national prevention strategy using big data analytics to devise
targeted prevention messages that employ cutting-edge methods of marketing and
communications.
Evidence-based prevention programs for schools, and tools for teachers and parents to
enhance youth knowledge of the dangers of drug use, as well as early intervention
strategies for children with environmental and individual risk factors (trauma, foster
care, adverse childhood experiences (ACEs), and developmental disorders).
The need for satisfaction with pain level as a satisfaction criteria through which health
care providers are evaluated by HHS.
Workforce access and training needs within the treatment community nationally, with a
particular focus on the regions of the country with the highest overdose deaths.
Improvements in treatment programs, based on adherence to principles of evidence-
based treatment, continuum of care, outcome measures, and patient education on
quality treatment.
Research initiatives and opportunities to combat the epidemic and enhance treatment
options, including alternative pain management strategies, and treatment for vulnerable
populations such as pregnant women, and substance-exposed infants through work by
the NIH, HHS, CDC, FDA, SAMHSA, and pharmaceutical partners.
Opportunities to further the practice of substance use screenings and referrals through
CMS quality measures.
Opportunities for patient protections providing better information about the risks and
benefits of taking prescription opioids.
Supply reduction of heroin, fentanyl analogs and counterfeit pills through coordinated
federal and state law enforcement initiatives.
Targeted data collection and analytics needed to identify most effective prevention and
treatment strategies, quality treatment access programs, reimbursements, and aid to
law enforcement activities. The possibility of a behavioral health surveillance system run
through CDC that tracks prevalence rates, treatment modalities, and comorbidities with
other illnesses in real-time.
Regulatory or statutory changes to reduce commercial insurance barriers to MAT, such
as dangerous fail-first protocols and onerous and frequent prior authorization
requirements.
In our final report, we will provide an additional set of detailed recommendations that, if
implemented, will ensure that the Federal Government operates as a strong partner in the fight
against addiction and the opioid crisis.
Finally, our country needs you, Mr. President. We know you care deeply about this issue. We
also know that you will use the authority of your office to deal with our nations problems. The
Commission looks forward to submitting its final report.
Sincerely,
Commission members
DRAFT/ADVISORY/CONSULTATIVE/DELIBERATIVE/CONFIDENTIAL
Appendix 4. Fentanyl Safety Recommendations for First Responders
DRAFT/ADVISORY/CONSULTATIVE/DELIBERATIVE/CONFIDENTIAL
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